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Acute Venous Thrombosis: Thrombus Removal With Adjunctive Catheter-Directed Thrombolysis (ATTRACT)

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ClinicalTrials.gov Identifier: NCT00790335
Recruitment Status : Completed
First Posted : November 13, 2008
Results First Posted : March 29, 2018
Last Update Posted : March 29, 2018
Sponsor:
Collaborators:
McMaster University
Ontario Clinical Oncology Group (OCOG)
National Heart, Lung, and Blood Institute (NHLBI)
BSN Medical Inc
Genentech, Inc.
Medtronic - MITG
Boston Scientific Corporation
Mid America Heart Institute
Society of Interventional Radiology Foundation
Massachusetts General Hospital
Information provided by (Responsible Party):
Washington University School of Medicine

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Deep Vein Thrombosis
Venous Thrombosis
Postphlebitic Syndrome
Venous Thromboembolism
Post Thrombotic Syndrome
Intervention Drug: Recombinant tissue plasminogen activator (rt-PA)
Enrollment 692
Recruitment Details  
Pre-assignment Details  
Arm/Group Title A-Intervention B-Control
Hide Arm/Group Description

Pharmacomechanical catheter-directed thrombolysis (PCDT) with intrathrombus delivery of rt-PA (maximum allowable total dose 35 mg) into the DVT over a period of up to 24 hours. Three methods of initial rt-PA delivery will be used: 1) Trellis-8 Peripheral Infusion System - maximum first-session rt-PA dose 25 mg; 2) AngioJet Rheolytic Thrombectomy System - maximum first-session rt-PA dose 25 mg; or 3) Catheter-directed rt-PA infusion for up to 24 hours at 0.01 mg/kg/hr (maximum 1.0 mg/hr) via a multisidehole infusion catheter. Before and after PCDT, patients will receive standard DVT therapy as in the Control Arm

Recombinant tissue plasminogen activator (rt-PA): Pharmacomechanical catheter-directed thrombolysis, consisting of intrathrombus administration of rt-PA using a catheter/device.

Initial anticoagulant therapy with unfractionated heparin, enoxaparin, dalteparin, or tinzaparin, for at least 5 days, overlapped with long-term oral warfarin (target international normalized ratio [INR} 2.0 - 3.0). Elastic compression stockings will be prescribed
Period Title: Overall Study
Started 337 355
Completed 257 243
Not Completed 80 112
Arm/Group Title A-Intervention B-Control Total
Hide Arm/Group Description

PCDT with intrathrombus delivery of rt-PA (maximum allowable total dose 35 mg) into the DVT over a period of up to 24 hours. Three methods of initial rt-PA delivery will be used: 1) Trellis-8 Peripheral Infusion System - maximum first-session rt-PA dose 25 mg; 2) AngioJet Rheolytic Thrombectomy System - maximum first-session rt-PA dose 25 mg; or 3) Catheter-directed rt-PA infusion for up to 24 hours at 0.01 mg/kg/hr (maximum 1.0 mg/hr) via a multisidehole infusion catheter. Before and after PCDT, patients will receive standard DVT therapy as in the Control Arm

Recombinant tissue plasminogen activator (rt-PA): Pharmacomechanical catheter-directed thrombolysis, consisting of intrathrombus administration of rt-PA using a catheter/device.

Initial anticoagulant therapy with unfractionated heparin, enoxaparin, dalteparin, or tinzaparin, for at least 5 days, overlapped with long-term oral warfarin (target INR 2.0 - 3.0). Elastic compression stockings will be prescribed Total of all reporting groups
Overall Number of Baseline Participants 336 355 691
Hide Baseline Analysis Population Description
One patient was found not to meet the study inclusion criterion, and was excluded from all analyses by the adjudication committee.
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 336 participants 355 participants 691 participants
52
(41 to 62)
53
(43 to 62)
53
(42 to 62)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 336 participants 355 participants 691 participants
Female
131
  39.0%
134
  37.7%
265
  38.4%
Male
205
  61.0%
221
  62.3%
426
  61.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 336 participants 355 participants 691 participants
Hispanic or Latino
15
   4.5%
26
   7.3%
41
   5.9%
Not Hispanic or Latino
310
  92.3%
319
  89.9%
629
  91.0%
Unknown or Not Reported
11
   3.3%
10
   2.8%
21
   3.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 336 participants 355 participants 691 participants
American Indian or Alaska Native
1
   0.3%
3
   0.8%
4
   0.6%
Asian
1
   0.3%
4
   1.1%
5
   0.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
61
  18.2%
62
  17.5%
123
  17.8%
White
265
  78.9%
276
  77.7%
541
  78.3%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
8
   2.4%
10
   2.8%
18
   2.6%
Body-mass index  
Median (Inter-Quartile Range)
Unit of measure:  Kilograms per square meter
Number Analyzed 336 participants 355 participants 691 participants
31
(27 to 36)
30
(26 to 35)
31
(27 to 35)
Symptom severity score   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 336 participants 355 participants 691 participants
None or very mild (0-4)
57
  17.0%
69
  19.4%
126
  18.2%
Mild (5-9)
115
  34.2%
124
  34.9%
239
  34.6%
Moderate (10-14)
98
  29.2%
94
  26.5%
192
  27.8%
Severe (> 14)
66
  19.6%
66
  18.6%
132
  19.1%
Not documented
0
   0.0%
2
   0.6%
2
   0.3%
[1]
Measure Description: The Villalta scale was used to define baseline symptom severity
Side of index DVT  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 336 participants 355 participants 691 participants
Left leg
207
  61.6%
218
  61.4%
425
  61.5%
Right leg
129
  38.4%
137
  38.6%
266
  38.5%
Previous DVT or PE   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 336 participants 355 participants 691 participants
83
  24.7%
87
  24.5%
170
  24.6%
[1]
Measure Description: DVT = deep vein thrombosis; PE = pulmonary embolism
Previous ipsilateral DVT   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 336 participants 355 participants 691 participants
5
   1.5%
14
   3.9%
19
   2.7%
[1]
Measure Description: DVT = deep vein thrombosis
DVT extends into iliac or common femoral vein   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 336 participants 355 participants 691 participants
195
  58.0%
196
  55.2%
391
  56.6%
[1]
Measure Description: Patients with DVT extending into the iliac or common femoral vein are termed "iliofemoral DVT" and those whose DVT did not extend that high are termed "femoropopliteal DVT".
DVT risk factors  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 336 participants 355 participants 691 participants
Major surgery
27
   8.0%
34
   9.6%
61
   8.8%
Hospitalization
26
   7.7%
38
  10.7%
64
   9.3%
Plaster cast immobilization
8
   2.4%
9
   2.5%
17
   2.5%
Childbirth
3
   0.9%
5
   1.4%
8
   1.2%
None of the above risk factors
272
  81.0%
269
  75.8%
541
  78.3%
Outpatient  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 336 participants 355 participants 691 participants
268
  79.8%
300
  84.5%
568
  82.2%
Time from symptom start to randomization  
Median (Inter-Quartile Range)
Unit of measure:  Days
Number Analyzed 336 participants 355 participants 691 participants
6
(4 to 10)
6
(4 to 9)
6
(4 to 10)
Aspirin use within past 7 days  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 336 participants 355 participants 691 participants
68
  20.2%
74
  20.8%
142
  20.5%
Estimated glomerular filtration rate  
Median (Inter-Quartile Range)
Unit of measure:  Milliliters per minute
Number Analyzed 336 participants 355 participants 691 participants
86
(70 to 102)
86
(71 to 102)
86
(71 to 102)
Hypertension  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 336 participants 355 participants 691 participants
143
  42.6%
139
  39.2%
282
  40.8%
Diabetes  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 336 participants 355 participants 691 participants
59
  17.6%
54
  15.2%
113
  16.4%
High cholesterol  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 336 participants 355 participants 691 participants
97
  28.9%
105
  29.6%
202
  29.2%
Asthma  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 336 participants 355 participants 691 participants
36
  10.7%
38
  10.7%
74
  10.7%
Chronic obstructive pulmonary disease   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 336 participants 355 participants 691 participants
9
   2.7%
15
   4.2%
24
   3.5%
[1]
Measure Description: COPD = chronic obstructive pulmonary disease
Angina or myocardial infarction   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 336 participants 355 participants 691 participants
13
   3.9%
15
   4.2%
28
   4.1%
[1]
Measure Description: MI = myocardial infarction
Congestive heart failure  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 336 participants 355 participants 691 participants
13
   3.9%
19
   5.4%
32
   4.6%
Height  
Mean (Standard Deviation)
Unit of measure:  Centimeters
Number Analyzed 336 participants 355 participants 691 participants
174  (11) 174  (10) 174  (11)
Weight  
Mean (Standard Deviation)
Unit of measure:  Kilograms
Number Analyzed 336 participants 355 participants 691 participants
97  (25) 96  (24) 97  (24)
1.Primary Outcome
Title Cumulative Incidence of Post-Thrombotic Syndrome (Villalta Scale)
Hide Description Patients who experienced one of the following occurrences in the index leg between the 6 month and 24 month post-randomization follow-up visits, inclusive: 1) Villalta score of 5 or greater; 2) leg ulcer; or 3) late endovascular procedure performed to treat severe venous disease. The Villalta scale ranges from 0-33 points, with higher scores being worse.
Time Frame Between 6 and 24 months after randomization
Hide Outcome Measure Data
Hide Analysis Population Description
Modified full analysis set; intention-to-treat
Arm/Group Title A-Intervention B-Control
Hide Arm/Group Description:

PCDT with intrathrombus delivery of rt-PA (maximum allowable total dose 35 mg) into the DVT over a period of up to 24 hours. Three methods of initial rt-PA delivery will be used: 1) Trellis-8 Peripheral Infusion System - maximum first-session rt-PA dose 25 mg; 2) AngioJet Rheolytic Thrombectomy System - maximum first-session rt-PA dose 25 mg; or 3) Catheter-directed rt-PA infusion for up to 24 hours at 0.01 mg/kg/hr (maximum 1.0 mg/hr) via a multisidehole infusion catheter. Before and after PCDT, patients will receive standard DVT therapy as in the Control Arm

Recombinant tissue plasminogen activator (rt-PA): Pharmacomechanical catheter-directed thrombolysis, consisting of intrathrombus administration of rt-PA using a catheter/device.

Initial anticoagulant therapy with unfractionated heparin, enoxaparin, dalteparin, or tinzaparin, for at least 5 days, overlapped with long-term oral warfarin (target INR 2.0 - 3.0). Elastic compression stockings will be prescribed
Overall Number of Participants Analyzed 336 355
Measure Type: Count of Participants
Unit of Measure: Participants
157
  46.7%
171
  48.2%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection A-Intervention, B-Control
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.56
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Adjusted for extent of DVT and for clinical center
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.96
Confidence Interval (2-Sided) 95%
0.82 to 1.11
Estimation Comments Numerator: PCDT Arm; Denominator: Control Arm. Primary outcome = no statistically significant difference between the two arms.
2.Secondary Outcome
Title Major Non-post-thrombotic Syndrome Treatment Failure
Hide Description A major non-post-thrombotic-syndrome treatment failure refers to when any of three events occurred in the index leg: 1) an unplanned endovascular procedure to treat severe venous symptoms within 6 months post-randomization; 2) venous gangrene within 6 months; or 3) an amputation within 24 months.
Time Frame Through 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
Modified full analysis set; intention to treat
Arm/Group Title A-Intervention B-Control
Hide Arm/Group Description:

PCDT with intrathrombus delivery of rt-PA (maximum allowable total dose 35 mg) into the DVT over a period of up to 24 hours. Three methods of initial rt-PA delivery will be used: 1) Trellis-8 Peripheral Infusion System - maximum first-session rt-PA dose 25 mg; 2) AngioJet Rheolytic Thrombectomy System - maximum first-session rt-PA dose 25 mg; or 3) Catheter-directed rt-PA infusion for up to 24 hours at 0.01 mg/kg/hr (maximum 1.0 mg/hr) via a multisidehole infusion catheter. Before and after PCDT, patients will receive standard DVT therapy as in the Control Arm

Recombinant tissue plasminogen activator (rt-PA): Pharmacomechanical catheter-directed thrombolysis, consisting of intrathrombus administration of rt-PA using a catheter/device.

Initial anticoagulant therapy with unfractionated heparin, enoxaparin, dalteparin, or tinzaparin, for at least 5 days, overlapped with long-term oral warfarin (target INR 2.0 - 3.0). Elastic compression stockings will be prescribed
Overall Number of Participants Analyzed 336 355
Measure Type: Count of Participants
Unit of Measure: Participants
4
   1.2%
7
   2.0%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection A-Intervention, B-Control
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.38
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Adjusted by extent of thrombus and clinical center
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.58
Confidence Interval (2-Sided) 95%
0.17 to 1.98
Estimation Comments Numerator: PCDT Arm; Denominator: Control Arm. No statistically significant difference was seen.
3.Secondary Outcome
Title Any Treatment Failure
Hide Description Composite of PTS and major non-PTS treatment failure
Time Frame Through 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
Modified full analysis set; intention to treat
Arm/Group Title A-Intervention B-Control
Hide Arm/Group Description:

PCDT with intrathrombus delivery of rt-PA (maximum allowable total dose 35 mg) into the DVT over a period of up to 24 hours. Three methods of initial rt-PA delivery will be used: 1) Trellis-8 Peripheral Infusion System - maximum first-session rt-PA dose 25 mg; 2) AngioJet Rheolytic Thrombectomy System - maximum first-session rt-PA dose 25 mg; or 3) Catheter-directed rt-PA infusion for up to 24 hours at 0.01 mg/kg/hr (maximum 1.0 mg/hr) via a multisidehole infusion catheter. Before and after PCDT, patients will receive standard DVT therapy as in the Control Arm

Recombinant tissue plasminogen activator (rt-PA): Pharmacomechanical catheter-directed thrombolysis, consisting of intrathrombus administration of rt-PA using a catheter/device.

Initial anticoagulant therapy with unfractionated heparin, enoxaparin, dalteparin, or tinzaparin, for at least 5 days, overlapped with long-term oral warfarin (target INR 2.0 - 3.0). Elastic compression stockings will be prescribed
Overall Number of Participants Analyzed 336 355
Measure Type: Count of Participants
Unit of Measure: Participants
158
  47.0%
176
  49.6%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection A-Intervention, B-Control
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.39
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Adjusted for thrombus extent and clinical center
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.94
Confidence Interval (2-Sided) 95%
0.80 to 1.09
Estimation Comments No statistically significant difference was seen.
4.Secondary Outcome
Title Moderate-to-severe Post-thrombotic Syndrome
Hide Description Proportion of patients with Villalta score of 10 or higher at any time between the 6 month and 24 month follow-up visits, inclusive. The Villalta scale ranges from 0-33 points, with higher scores being worse.
Time Frame Between 6 and 24 months after randomization
Hide Outcome Measure Data
Hide Analysis Population Description
Modified full analysis set, intention-to-treat
Arm/Group Title A-Intervention B-Control
Hide Arm/Group Description:

PCDT with intrathrombus delivery of rt-PA (maximum allowable total dose 35 mg) into the DVT over a period of up to 24 hours. Three methods of initial rt-PA delivery will be used: 1) Trellis-8 Peripheral Infusion System - maximum first-session rt-PA dose 25 mg; 2) AngioJet Rheolytic Thrombectomy System - maximum first-session rt-PA dose 25 mg; or 3) Catheter-directed rt-PA infusion for up to 24 hours at 0.01 mg/kg/hr (maximum 1.0 mg/hr) via a multisidehole infusion catheter. Before and after PCDT, patients will receive standard DVT therapy as in the Control Arm

Recombinant tissue plasminogen activator (rt-PA): Pharmacomechanical catheter-directed thrombolysis, consisting of intrathrombus administration of rt-PA using a catheter/device.

Initial anticoagulant therapy with unfractionated heparin, enoxaparin, dalteparin, or tinzaparin, for at least 5 days, overlapped with long-term oral warfarin (target INR 2.0 - 3.0). Elastic compression stockings will be prescribed
Overall Number of Participants Analyzed 336 355
Measure Type: Count of Participants
Unit of Measure: Participants
60
  17.9%
84
  23.7%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection A-Intervention, B-Control
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.04
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Adjusted by extent of DVT and clinical center
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.73
Confidence Interval (2-Sided) 95%
0.54 to 0.98
Estimation Comments Numerator: PCDT Arm; Denominator: Control Arm
5.Secondary Outcome
Title Major Bleeding
Hide Description Defined as clinically overt bleeding that is associated with a fall in the hemoglobin level of at least 2.0 g/dl, transfusion of ≥ 2 units of red blood cells, or involvement of a critical site (e.g. intracranial, intraspinal).
Time Frame Within 10 days after randomization
Hide Outcome Measure Data
Hide Analysis Population Description
Modified full analysis set, intention-to-treat
Arm/Group Title A-Intervention B-Control
Hide Arm/Group Description:

PCDT with intrathrombus delivery of rt-PA (maximum allowable total dose 35 mg) into the DVT over a period of up to 24 hours. Three methods of initial rt-PA delivery will be used: 1) Trellis-8 Peripheral Infusion System - maximum first-session rt-PA dose 25 mg; 2) AngioJet Rheolytic Thrombectomy System - maximum first-session rt-PA dose 25 mg; or 3) Catheter-directed rt-PA infusion for up to 24 hours at 0.01 mg/kg/hr (maximum 1.0 mg/hr) via a multisidehole infusion catheter. Before and after PCDT, patients will receive standard DVT therapy as in the Control Arm

Recombinant tissue plasminogen activator (rt-PA): Pharmacomechanical catheter-directed thrombolysis, consisting of intrathrombus administration of rt-PA using a catheter/device.

Initial anticoagulant therapy with unfractionated heparin, enoxaparin, dalteparin, or tinzaparin, for at least 5 days, overlapped with long-term oral warfarin (target INR 2.0 - 3.0). Elastic compression stockings will be prescribed
Overall Number of Participants Analyzed 336 355
Measure Type: Count of Participants
Unit of Measure: Participants
6
   1.8%
1
   0.3%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection A-Intervention, B-Control
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.049
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 6.18
Confidence Interval (2-Sided) 95%
0.78 to 49.2
Estimation Comments Numerator: PCDT Arm; Denominator: Control Arm. More major bleeding was observed in the PCDT Arm.
6.Secondary Outcome
Title Major Bleeding
Hide Description Defined as clinically overt bleeding that was associated with a fall in the hemoglobin level of at least 2.0 g/dl, transfusion of ≥ 2 units of red blood cells, or involvement of a critical site (e.g. intracranial, intraspinal).
Time Frame Within 24 months after randomization
Hide Outcome Measure Data
Hide Analysis Population Description
Modified full analysis set; intention-to-treat
Arm/Group Title A-Intervention B-Control
Hide Arm/Group Description:

PCDT with intrathrombus delivery of rt-PA (maximum allowable total dose 35 mg) into the DVT over a period of up to 24 hours. Three methods of initial rt-PA delivery will be used: 1) Trellis-8 Peripheral Infusion System - maximum first-session rt-PA dose 25 mg; 2) AngioJet Rheolytic Thrombectomy System - maximum first-session rt-PA dose 25 mg; or 3) Catheter-directed rt-PA infusion for up to 24 hours at 0.01 mg/kg/hr (maximum 1.0 mg/hr) via a multisidehole infusion catheter. Before and after PCDT, patients will receive standard DVT therapy as in the Control Arm

Recombinant tissue plasminogen activator (rt-PA): Pharmacomechanical catheter-directed thrombolysis, consisting of intrathrombus administration of rt-PA using a catheter/device.

Initial anticoagulant therapy with unfractionated heparin, enoxaparin, dalteparin, or tinzaparin, for at least 5 days, overlapped with long-term oral warfarin (target INR 2.0 - 3.0). Elastic compression stockings will be prescribed
Overall Number of Participants Analyzed 336 355
Measure Type: Count of Participants
Unit of Measure: Participants
19
   5.7%
13
   3.7%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection A-Intervention, B-Control
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.23
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.52
Confidence Interval (2-Sided) 95%
0.76 to 3.01
Estimation Comments Numerator: PCDT Arm; Denominator: Control Arm
7.Secondary Outcome
Title Any (Minor + Major) Bleeding
Hide Description Clinically overt bleeding that occurred through 10 days post-randomization
Time Frame Within 10 days after randomization
Hide Outcome Measure Data
Hide Analysis Population Description
Modified full analysis set, intention-to-treat
Arm/Group Title A-Intervention B-Control
Hide Arm/Group Description:

PCDT with intrathrombus delivery of rt-PA (maximum allowable total dose 35 mg) into the DVT over a period of up to 24 hours. Three methods of initial rt-PA delivery will be used: 1) Trellis-8 Peripheral Infusion System - maximum first-session rt-PA dose 25 mg; 2) AngioJet Rheolytic Thrombectomy System - maximum first-session rt-PA dose 25 mg; or 3) Catheter-directed rt-PA infusion for up to 24 hours at 0.01 mg/kg/hr (maximum 1.0 mg/hr) via a multisidehole infusion catheter. Before and after PCDT, patients will receive standard DVT therapy as in the Control Arm

Recombinant tissue plasminogen activator (rt-PA): Pharmacomechanical catheter-directed thrombolysis, consisting of intrathrombus administration of rt-PA using a catheter/device.

Initial anticoagulant therapy with unfractionated heparin, enoxaparin, dalteparin, or tinzaparin, for at least 5 days, overlapped with long-term oral warfarin (target INR 2.0 - 3.0). Elastic compression stockings will be prescribed
Overall Number of Participants Analyzed 336 355
Measure Type: Count of Participants
Unit of Measure: Participants
15
   4.5%
6
   1.7%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection A-Intervention, B-Control
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.03
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 2.64
Confidence Interval (2-Sided) 95%
1.04 to 6.68
Estimation Comments Numerator = PCDT Arm; Denominator = Control Arm. Bleeding was more frequent in the PCDT Arm.
8.Secondary Outcome
Title Any (Major + Minor) Bleeding
Hide Description Clinically overt bleeding that occurred within 24 months post-randomization
Time Frame Within 24 months after randomization
Hide Outcome Measure Data
Hide Analysis Population Description
Modified full analysis set, intention-to-treat
Arm/Group Title A-Intervention B-Control
Hide Arm/Group Description:

PCDT with intrathrombus delivery of rt-PA (maximum allowable total dose 35 mg) into the DVT over a period of up to 24 hours. Three methods of initial rt-PA delivery will be used: 1) Trellis-8 Peripheral Infusion System - maximum first-session rt-PA dose 25 mg; 2) AngioJet Rheolytic Thrombectomy System - maximum first-session rt-PA dose 25 mg; or 3) Catheter-directed rt-PA infusion for up to 24 hours at 0.01 mg/kg/hr (maximum 1.0 mg/hr) via a multisidehole infusion catheter. Before and after PCDT, patients will receive standard DVT therapy as in the Control Arm

Recombinant tissue plasminogen activator (rt-PA): Pharmacomechanical catheter-directed thrombolysis, consisting of intrathrombus administration of rt-PA using a catheter/device.

Initial anticoagulant therapy with unfractionated heparin, enoxaparin, dalteparin, or tinzaparin, for at least 5 days, overlapped with long-term oral warfarin (target INR 2.0 - 3.0). Elastic compression stockings will be prescribed
Overall Number of Participants Analyzed 336 355
Measure Type: Count of Participants
Unit of Measure: Participants
46
  13.7%
38
  10.7%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection A-Intervention, B-Control
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.25
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.26
Confidence Interval (2-Sided) 95%
0.85 to 1.89
Estimation Comments Numerator: PCDT Arm; Denominator: Control Arm
9.Secondary Outcome
Title Recurrent Venous Thromboembolism
Hide Description Proportion of patients with symptomatic recurrent venous thromboembolism (including DVT and/or PE)
Time Frame Within 10 days after randomization
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title A-Intervention B-Control
Hide Arm/Group Description:

PCDT with intrathrombus delivery of rt-PA (maximum allowable total dose 35 mg) into the DVT over a period of up to 24 hours. Three methods of initial rt-PA delivery will be used: 1) Trellis-8 Peripheral Infusion System - maximum first-session rt-PA dose 25 mg; 2) AngioJet Rheolytic Thrombectomy System - maximum first-session rt-PA dose 25 mg; or 3) Catheter-directed rt-PA infusion for up to 24 hours at 0.01 mg/kg/hr (maximum 1.0 mg/hr) via a multisidehole infusion catheter. Before and after PCDT, patients will receive standard DVT therapy as in the Control Arm

Recombinant tissue plasminogen activator (rt-PA): Pharmacomechanical catheter-directed thrombolysis, consisting of intrathrombus administration of rt-PA using a catheter/device.

Initial anticoagulant therapy with unfractionated heparin, enoxaparin, dalteparin, or tinzaparin, for at least 5 days, overlapped with long-term oral warfarin (target INR 2.0 - 3.0). Elastic compression stockings will be prescribed
Overall Number of Participants Analyzed 336 355
Measure Type: Count of Participants
Unit of Measure: Participants
6
   1.8%
4
   1.1%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection A-Intervention, B-Control
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.50
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.53
Confidence Interval (2-Sided) 95%
0.44 to 5.28
Estimation Comments Numerator = PCDT Arm; Denominator = Control Arm
10.Secondary Outcome
Title Recurrent Venous Thromboembolism
Hide Description Symptomatic recurrent venous thromboembolism (DVT and/or PE)
Time Frame Within 24 months after randomization
Hide Outcome Measure Data
Hide Analysis Population Description
Modified full analysis set; intention to treat
Arm/Group Title A-Intervention B-Control
Hide Arm/Group Description:

PCDT with intrathrombus delivery of rt-PA (maximum allowable total dose 35 mg) into the DVT over a period of up to 24 hours. Three methods of initial rt-PA delivery will be used: 1) Trellis-8 Peripheral Infusion System - maximum first-session rt-PA dose 25 mg; 2) AngioJet Rheolytic Thrombectomy System - maximum first-session rt-PA dose 25 mg; or 3) Catheter-directed rt-PA infusion for up to 24 hours at 0.01 mg/kg/hr (maximum 1.0 mg/hr) via a multisidehole infusion catheter. Before and after PCDT, patients will receive standard DVT therapy as in the Control Arm

Recombinant tissue plasminogen activator (rt-PA): Pharmacomechanical catheter-directed thrombolysis, consisting of intrathrombus administration of rt-PA using a catheter/device.

Initial anticoagulant therapy with unfractionated heparin, enoxaparin, dalteparin, or tinzaparin, for at least 5 days, overlapped with long-term oral warfarin (target INR 2.0 - 3.0). Elastic compression stockings will be prescribed
Overall Number of Participants Analyzed 336 355
Measure Type: Count of Participants
Unit of Measure: Participants
42
  12.5%
30
   8.5%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection A-Intervention, B-Control
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.09
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.47
Confidence Interval (2-Sided) 95%
0.94 to 2.29
Estimation Comments Numerator: PCDT Arm; Denominator: Control Arm
11.Secondary Outcome
Title Death
Hide Description All-cause mortality
Time Frame Within 10 days after randomization
Hide Outcome Measure Data
Hide Analysis Population Description
Modified full analysis set; intention to treat
Arm/Group Title A-Intervention B-Control
Hide Arm/Group Description:

PCDT with intrathrombus delivery of rt-PA (maximum allowable total dose 35 mg) into the DVT over a period of up to 24 hours. Three methods of initial rt-PA delivery will be used: 1) Trellis-8 Peripheral Infusion System - maximum first-session rt-PA dose 25 mg; 2) AngioJet Rheolytic Thrombectomy System - maximum first-session rt-PA dose 25 mg; or 3) Catheter-directed rt-PA infusion for up to 24 hours at 0.01 mg/kg/hr (maximum 1.0 mg/hr) via a multisidehole infusion catheter. Before and after PCDT, patients will receive standard DVT therapy as in the Control Arm

Recombinant tissue plasminogen activator (rt-PA): Pharmacomechanical catheter-directed thrombolysis, consisting of intrathrombus administration of rt-PA using a catheter/device.

Initial anticoagulant therapy with unfractionated heparin, enoxaparin, dalteparin, or tinzaparin, for at least 5 days, overlapped with long-term oral warfarin (target INR 2.0 - 3.0). Elastic compression stockings will be prescribed
Overall Number of Participants Analyzed 336 355
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
12.Secondary Outcome
Title Death
Hide Description All-cause mortality
Time Frame Within 24 months after randomization
Hide Outcome Measure Data
Hide Analysis Population Description
Modified full analysis set; intention to treat
Arm/Group Title A-Intervention B-Control
Hide Arm/Group Description:

PCDT with intrathrombus delivery of rt-PA (maximum allowable total dose 35 mg) into the DVT over a period of up to 24 hours. Three methods of initial rt-PA delivery will be used: 1) Trellis-8 Peripheral Infusion System - maximum first-session rt-PA dose 25 mg; 2) AngioJet Rheolytic Thrombectomy System - maximum first-session rt-PA dose 25 mg; or 3) Catheter-directed rt-PA infusion for up to 24 hours at 0.01 mg/kg/hr (maximum 1.0 mg/hr) via a multisidehole infusion catheter. Before and after PCDT, patients will receive standard DVT therapy as in the Control Arm

Recombinant tissue plasminogen activator (rt-PA): Pharmacomechanical catheter-directed thrombolysis, consisting of intrathrombus administration of rt-PA using a catheter/device.

Initial anticoagulant therapy with unfractionated heparin, enoxaparin, dalteparin, or tinzaparin, for at least 5 days, overlapped with long-term oral warfarin (target INR 2.0 - 3.0). Elastic compression stockings will be prescribed
Overall Number of Participants Analyzed 336 355
Measure Type: Count of Participants
Unit of Measure: Participants
7
   2.1%
8
   2.3%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection A-Intervention, B-Control
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.83
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.89
Confidence Interval (2-Sided) 95%
0.33 to 2.44
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Severity of Post-thrombotic Syndrome (Villalta)
Hide Description Mean Villalta scale score at the specified follow-up visit. Villalta score ranges from 0-33 points, with higher scores being worse.
Time Frame At 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Modified full analysis set; intention to treat
Arm/Group Title A-Intervention B-Control
Hide Arm/Group Description:

PCDT with intrathrombus delivery of rt-PA (maximum allowable total dose 35 mg) into the DVT over a period of up to 24 hours. Three methods of initial rt-PA delivery will be used: 1) Trellis-8 Peripheral Infusion System - maximum first-session rt-PA dose 25 mg; 2) AngioJet Rheolytic Thrombectomy System - maximum first-session rt-PA dose 25 mg; or 3) Catheter-directed rt-PA infusion for up to 24 hours at 0.01 mg/kg/hr (maximum 1.0 mg/hr) via a multisidehole infusion catheter. Before and after PCDT, patients will receive standard DVT therapy as in the Control Arm

Recombinant tissue plasminogen activator (rt-PA): Pharmacomechanical catheter-directed thrombolysis, consisting of intrathrombus administration of rt-PA using a catheter/device.

Initial anticoagulant therapy with unfractionated heparin, enoxaparin, dalteparin, or tinzaparin, for at least 5 days, overlapped with long-term oral warfarin (target INR 2.0 - 3.0). Elastic compression stockings will be prescribed
Overall Number of Participants Analyzed 291 285
Mean (Standard Error)
Unit of Measure: points
3.11  (0.24) 4.33  (0.24)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection A-Intervention, B-Control
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Regression, Linear
Comments Piecewise linear-regression growth-curve models with adjustment for extent of DVT, clinical center) and pre-specified baseline co-variates
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.22
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.31
Estimation Comments Lower (better) mean scores in the PCDT Arm
14.Secondary Outcome
Title Severity of Post-thrombotic Syndrome (Villalta)
Hide Description Mean Villalta scale score at the specified follow-up visit. Villalta score ranges from 0-33 points, with higher scores being worse.
Time Frame At 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Modified full analysis set; intention to treat
Arm/Group Title A-Intervention B-Control
Hide Arm/Group Description:

PCDT with intrathrombus delivery of rt-PA (maximum allowable total dose 35 mg) into the DVT over a period of up to 24 hours. Three methods of initial rt-PA delivery will be used: 1) Trellis-8 Peripheral Infusion System - maximum first-session rt-PA dose 25 mg; 2) AngioJet Rheolytic Thrombectomy System - maximum first-session rt-PA dose 25 mg; or 3) Catheter-directed rt-PA infusion for up to 24 hours at 0.01 mg/kg/hr (maximum 1.0 mg/hr) via a multisidehole infusion catheter. Before and after PCDT, patients will receive standard DVT therapy as in the Control Arm

Recombinant tissue plasminogen activator (rt-PA): Pharmacomechanical catheter-directed thrombolysis, consisting of intrathrombus administration of rt-PA using a catheter/device.

Initial anticoagulant therapy with unfractionated heparin, enoxaparin, dalteparin, or tinzaparin, for at least 5 days, overlapped with long-term oral warfarin (target INR 2.0 - 3.0). Elastic compression stockings will be prescribed
Overall Number of Participants Analyzed 272 258
Mean (Standard Error)
Unit of Measure: points
3.22  (0.22) 4.38  (0.22)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection A-Intervention, B-Control
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Regression, Linear
Comments Piecewise linear-regression growth-curve models with adjustment for extent of DVT, clinical center) and pre-specified baseline co-variates
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.17
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.28
Estimation Comments Lower (better) mean scores in the PCDT Arm
15.Secondary Outcome
Title Severity of Post-thrombotic Syndrome (Villalta)
Hide Description Mean Villalta scale score at specified follow-up visit. Villalta score ranges from 0-33 points, with higher scores being worse.
Time Frame At 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
Modified full analysis set; intention to treat
Arm/Group Title A-Intervention B-Control
Hide Arm/Group Description:

PCDT with intrathrombus delivery of rt-PA (maximum allowable total dose 35 mg) into the DVT over a period of up to 24 hours. Three methods of initial rt-PA delivery will be used: 1) Trellis-8 Peripheral Infusion System - maximum first-session rt-PA dose 25 mg; 2) AngioJet Rheolytic Thrombectomy System - maximum first-session rt-PA dose 25 mg; or 3) Catheter-directed rt-PA infusion for up to 24 hours at 0.01 mg/kg/hr (maximum 1.0 mg/hr) via a multisidehole infusion catheter. Before and after PCDT, patients will receive standard DVT therapy as in the Control Arm

Recombinant tissue plasminogen activator (rt-PA): Pharmacomechanical catheter-directed thrombolysis, consisting of intrathrombus administration of rt-PA using a catheter/device.

Initial anticoagulant therapy with unfractionated heparin, enoxaparin, dalteparin, or tinzaparin, for at least 5 days, overlapped with long-term oral warfarin (target INR 2.0 - 3.0). Elastic compression stockings will be prescribed
Overall Number of Participants Analyzed 245 222
Mean (Standard Error)
Unit of Measure: points
3.32  (0.24) 4.44  (0.24)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection A-Intervention, B-Control
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Regression, Linear
Comments Piecewise linear-regression growth-curve models with adjustment for extent of DVT, clinical center) and pre-specified baseline co-variates
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.12
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.31
Estimation Comments Lower (better) mean scores in the PCDT Arm
16.Secondary Outcome
Title Severity of Post-thrombotic Syndrome (Villalta)
Hide Description Mean Villalta scale score at specified follow-up visit. Villalta score ranges from 0-33 points, with higher scores being worse.
Time Frame At 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
Modified full analysis set; intention to treat
Arm/Group Title A-Intervention B-Control
Hide Arm/Group Description:

PCDT with intrathrombus delivery of rt-PA (maximum allowable total dose 35 mg) into the DVT over a period of up to 24 hours. Three methods of initial rt-PA delivery will be used: 1) Trellis-8 Peripheral Infusion System - maximum first-session rt-PA dose 25 mg; 2) AngioJet Rheolytic Thrombectomy System - maximum first-session rt-PA dose 25 mg; or 3) Catheter-directed rt-PA infusion for up to 24 hours at 0.01 mg/kg/hr (maximum 1.0 mg/hr) via a multisidehole infusion catheter. Before and after PCDT, patients will receive standard DVT therapy as in the Control Arm

Recombinant tissue plasminogen activator (rt-PA): Pharmacomechanical catheter-directed thrombolysis, consisting of intrathrombus administration of rt-PA using a catheter/device.

Initial anticoagulant therapy with unfractionated heparin, enoxaparin, dalteparin, or tinzaparin, for at least 5 days, overlapped with long-term oral warfarin (target INR 2.0 - 3.0). Elastic compression stockings will be prescribed
Overall Number of Participants Analyzed 258 239
Mean (Standard Error)
Unit of Measure: points
3.43  (0.28) 4.50  (0.29)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection A-Intervention, B-Control
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.005
Comments [Not Specified]
Method Regression, Linear
Comments Piecewise linear-regression growth-curve models with adjustment for extent of DVT, clinical center) and pre-specified baseline co-variates
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.06
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.38
Estimation Comments Lower (better) mean scores in the PCDT Arm
17.Secondary Outcome
Title Venous Clinical Severity Score
Hide Description Mean Venous Clinical Severity Score (VCSS) at the specified follow-up visit; range 0-27 (did not use compression item), higher score is worse
Time Frame At 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Modified full analysis set; intention to treat
Arm/Group Title A-Intervention B-Control
Hide Arm/Group Description:

PCDT with intrathrombus delivery of rt-PA (maximum allowable total dose 35 mg) into the DVT over a period of up to 24 hours. Three methods of initial rt-PA delivery will be used: 1) Trellis-8 Peripheral Infusion System - maximum first-session rt-PA dose 25 mg; 2) AngioJet Rheolytic Thrombectomy System - maximum first-session rt-PA dose 25 mg; or 3) Catheter-directed rt-PA infusion for up to 24 hours at 0.01 mg/kg/hr (maximum 1.0 mg/hr) via a multisidehole infusion catheter. Before and after PCDT, patients will receive standard DVT therapy as in the Control Arm

Recombinant tissue plasminogen activator (rt-PA): Pharmacomechanical catheter-directed thrombolysis, consisting of intrathrombus administration of rt-PA using a catheter/device.

Initial anticoagulant therapy with unfractionated heparin, enoxaparin, dalteparin, or tinzaparin, for at least 5 days, overlapped with long-term oral warfarin (target INR 2.0 - 3.0). Elastic compression stockings will be prescribed
Overall Number of Participants Analyzed 289 279
Mean (Standard Error)
Unit of Measure: points
1.73  (0.15) 2.68  (0.15)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection A-Intervention, B-Control
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Regression, Linear
Comments Piecewise linear-regression growth-curve models with adjustment for extent of DVT, clinical center) and pre-specified baseline co-variates
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.95
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.21
Estimation Comments Lower (better) mean scores in the PCDT Arm
18.Secondary Outcome
Title Venous Clinical Severity Score
Hide Description Mean VCSS score at the specified follow-up visit; range 0-27 (did not use compression item)
Time Frame At 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Modified full analysis set; intention to treat
Arm/Group Title A-Intervention B-Control
Hide Arm/Group Description:

PCDT with intrathrombus delivery of rt-PA (maximum allowable total dose 35 mg) into the DVT over a period of up to 24 hours. Three methods of initial rt-PA delivery will be used: 1) Trellis-8 Peripheral Infusion System - maximum first-session rt-PA dose 25 mg; 2) AngioJet Rheolytic Thrombectomy System - maximum first-session rt-PA dose 25 mg; or 3) Catheter-directed rt-PA infusion for up to 24 hours at 0.01 mg/kg/hr (maximum 1.0 mg/hr) via a multisidehole infusion catheter. Before and after PCDT, patients will receive standard DVT therapy as in the Control Arm

Recombinant tissue plasminogen activator (rt-PA): Pharmacomechanical catheter-directed thrombolysis, consisting of intrathrombus administration of rt-PA using a catheter/device.

Initial anticoagulant therapy with unfractionated heparin, enoxaparin, dalteparin, or tinzaparin, for at least 5 days, overlapped with long-term oral warfarin (target INR 2.0 - 3.0). Elastic compression stockings will be prescribed
Overall Number of Participants Analyzed 265 253
Mean (Standard Error)
Unit of Measure: points
1.80  (0.16) 2.37  (0.16)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection A-Intervention, B-Control
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.01
Comments [Not Specified]
Method Regression, Linear
Comments Piecewise linear-regression growth-curve models with adjustment for extent of DVT, clinical center) and pre-specified baseline co-variates
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.56
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.23
Estimation Comments Lower (better) mean scores in the PCDT Arm
19.Secondary Outcome
Title Venous Clinical Severity Score
Hide Description Mean VCSS score at the specified follow-up visit; range 0-27 (did not use compression item)
Time Frame At 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
Modified full analysis set; intention to treat
Arm/Group Title A-Intervention B-Control
Hide Arm/Group Description:

PCDT with intrathrombus delivery of rt-PA (maximum allowable total dose 35 mg) into the DVT over a period of up to 24 hours. Three methods of initial rt-PA delivery will be used: 1) Trellis-8 Peripheral Infusion System - maximum first-session rt-PA dose 25 mg; 2) AngioJet Rheolytic Thrombectomy System - maximum first-session rt-PA dose 25 mg; or 3) Catheter-directed rt-PA infusion for up to 24 hours at 0.01 mg/kg/hr (maximum 1.0 mg/hr) via a multisidehole infusion catheter. Before and after PCDT, patients will receive standard DVT therapy as in the Control Arm

Recombinant tissue plasminogen activator (rt-PA): Pharmacomechanical catheter-directed thrombolysis, consisting of intrathrombus administration of rt-PA using a catheter/device.

Initial anticoagulant therapy with unfractionated heparin, enoxaparin, dalteparin, or tinzaparin, for at least 5 days, overlapped with long-term oral warfarin (target INR 2.0 - 3.0). Elastic compression stockings will be prescribed
Overall Number of Participants Analyzed 240 215
Mean (Standard Error)
Unit of Measure: points
1.74  (0.17) 2.80  (0.18)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection A-Intervention, B-Control
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Regression, Linear
Comments Piecewise linear-regression growth-curve models with adjustment for extent of DVT, clinical center) and pre-specified baseline co-variates
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.06
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.24
Estimation Comments Lower (better) mean scores in the PCDT Arm
20.Secondary Outcome
Title Venous Clinical Severity Score
Hide Description Mean VCSS score at the specified follow-up visit; range 0-27 (did not use compression item)
Time Frame At 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
Modified full analysis set; intention to treat
Arm/Group Title A-Intervention B-Control
Hide Arm/Group Description:

PCDT with intrathrombus delivery of rt-PA (maximum allowable total dose 35 mg) into the DVT over a period of up to 24 hours. Three methods of initial rt-PA delivery will be used: 1) Trellis-8 Peripheral Infusion System - maximum first-session rt-PA dose 25 mg; 2) AngioJet Rheolytic Thrombectomy System - maximum first-session rt-PA dose 25 mg; or 3) Catheter-directed rt-PA infusion for up to 24 hours at 0.01 mg/kg/hr (maximum 1.0 mg/hr) via a multisidehole infusion catheter. Before and after PCDT, patients will receive standard DVT therapy as in the Control Arm

Recombinant tissue plasminogen activator (rt-PA): Pharmacomechanical catheter-directed thrombolysis, consisting of intrathrombus administration of rt-PA using a catheter/device.

Initial anticoagulant therapy with unfractionated heparin, enoxaparin, dalteparin, or tinzaparin, for at least 5 days, overlapped with long-term oral warfarin (target INR 2.0 - 3.0). Elastic compression stockings will be prescribed
Overall Number of Participants Analyzed 235 214
Mean (Standard Error)
Unit of Measure: points
1.87  (0.18) 2.42  (0.19)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection A-Intervention, B-Control
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.03
Comments [Not Specified]
Method Regression, Linear
Comments Piecewise linear-regression growth-curve models with adjustment for extent of DVT, clinical center) and pre-specified baseline co-variates
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.55
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.26
Estimation Comments Lower (better) mean scores in the PCDT Arm
21.Secondary Outcome
Title Change in General Quality of Life - Physical
Hide Description Short-Form-36 Health Survey, Version 2, Physical Component Summary (PCS) Scale. Range of scores 0-100 with higher scores representing better quality of life.
Time Frame Baseline to 24 months post-randomization
Hide Outcome Measure Data
Hide Analysis Population Description
Modified full analysis set; intention to treat
Arm/Group Title A-Intervention B-Control
Hide Arm/Group Description:

PCDT with intrathrombus delivery of rt-PA (maximum allowable total dose 35 mg) into the DVT over a period of up to 24 hours. Three methods of initial rt-PA delivery will be used: 1) Trellis-8 Peripheral Infusion System - maximum first-session rt-PA dose 25 mg; 2) AngioJet Rheolytic Thrombectomy System - maximum first-session rt-PA dose 25 mg; or 3) Catheter-directed rt-PA infusion for up to 24 hours at 0.01 mg/kg/hr (maximum 1.0 mg/hr) via a multisidehole infusion catheter. Before and after PCDT, patients will receive standard DVT therapy as in the Control Arm

Recombinant tissue plasminogen activator (rt-PA): Pharmacomechanical catheter-directed thrombolysis, consisting of intrathrombus administration of rt-PA using a catheter/device.

Initial anticoagulant therapy with unfractionated heparin, enoxaparin, dalteparin, or tinzaparin, for at least 5 days, overlapped with long-term oral warfarin (target INR 2.0 - 3.0). Elastic compression stockings will be prescribed
Overall Number of Participants Analyzed 245 222
Mean (Standard Error)
Unit of Measure: units on a scale
11.18  (0.91) 10.06  (2.70)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection A-Intervention, B-Control
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.37
Comments [Not Specified]
Method Regression, Linear
Comments Adjusted by extent of thrombus and clinical center
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 1.13
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.26
Estimation Comments No significant difference was seen in the degree of change from baseline to 24 months between the two treatment arms.
22.Secondary Outcome
Title Change in General Quality of Life - Mental
Hide Description Short-Form-36 Health Survey, Version 2, Mental Component Summary (MCS) Scale. Range of scores 0-100 with higher scores representing better quality of life.
Time Frame Baseline to 24 months post-randomization
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title A-Intervention B-Control
Hide Arm/Group Description:

PCDT with intrathrombus delivery of rt-PA (maximum allowable total dose 35 mg) into the DVT over a period of up to 24 hours. Three methods of initial rt-PA delivery will be used: 1) Trellis-8 Peripheral Infusion System - maximum first-session rt-PA dose 25 mg; 2) AngioJet Rheolytic Thrombectomy System - maximum first-session rt-PA dose 25 mg; or 3) Catheter-directed rt-PA infusion for up to 24 hours at 0.01 mg/kg/hr (maximum 1.0 mg/hr) via a multisidehole infusion catheter. Before and after PCDT, patients will receive standard DVT therapy as in the Control Arm

Recombinant tissue plasminogen activator (rt-PA): Pharmacomechanical catheter-directed thrombolysis, consisting of intrathrombus administration of rt-PA using a catheter/device.

Initial anticoagulant therapy with unfractionated heparin, enoxaparin, dalteparin, or tinzaparin, for at least 5 days, overlapped with long-term oral warfarin (target INR 2.0 - 3.0). Elastic compression stockings will be prescribed
Overall Number of Participants Analyzed 245 222
Mean (Standard Error)
Unit of Measure: units on a scale
2.70  (0.84) 2.70  (0.89)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection A-Intervention, B-Control
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.99
Comments [Not Specified]
Method Regression, Linear
Comments Adjusted by extent of thrombus and clinical center
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.00
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.16
Estimation Comments No difference was observed in the degree of change from baseline to 24 months in the two treatment groups.
23.Secondary Outcome
Title Change in Venous Disease-specific Quality of Life
Hide Description Venous Insufficiency Epidemiological and Economic Study Quality of Life (VEINES-QOL) questionnaire. Range of scores 0-100 with higher scores representing better quality of life, and higher change scores representing greater improvement from baseline.
Time Frame Baseline to 24 months post-randomization
Hide Outcome Measure Data
Hide Analysis Population Description
Modified full analysis set; intention to treat
Arm/Group Title A-Intervention B-Control
Hide Arm/Group Description:

PCDT with intrathrombus delivery of rt-PA (maximum allowable total dose 35 mg) into the DVT over a period of up to 24 hours. Three methods of initial rt-PA delivery will be used: 1) Trellis-8 Peripheral Infusion System - maximum first-session rt-PA dose 25 mg; 2) AngioJet Rheolytic Thrombectomy System - maximum first-session rt-PA dose 25 mg; or 3) Catheter-directed rt-PA infusion for up to 24 hours at 0.01 mg/kg/hr (maximum 1.0 mg/hr) via a multisidehole infusion catheter. Before and after PCDT, patients will receive standard DVT therapy as in the Control Arm

Recombinant tissue plasminogen activator (rt-PA): Pharmacomechanical catheter-directed thrombolysis, consisting of intrathrombus administration of rt-PA using a catheter/device.

Initial anticoagulant therapy with unfractionated heparin, enoxaparin, dalteparin, or tinzaparin, for at least 5 days, overlapped with long-term oral warfarin (target INR 2.0 - 3.0). Elastic compression stockings will be prescribed
Overall Number of Participants Analyzed 249 226
Mean (Standard Error)
Unit of Measure: units on a scale
27.67  (1.71) 23.47  (17.31)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection A-Intervention, B-Control
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.08
Comments [Not Specified]
Method Regression, Linear
Comments Adjusted by extent of thrombus and clinical center
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 4.20
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.39
Estimation Comments No significant difference in the change from baseline to 24 months between the two treatment arms.
24.Secondary Outcome
Title Change in Leg Pain Severity
Hide Description Likert pain scale ranging from 1-7, with higher scores representing a greater intensity of pain
Time Frame Baseline to 10 days post-randomization
Hide Outcome Measure Data
Hide Analysis Population Description
Modified full analysis set; intention to treat
Arm/Group Title A-Intervention B-Control
Hide Arm/Group Description:

PCDT with intrathrombus delivery of rt-PA (maximum allowable total dose 35 mg) into the DVT over a period of up to 24 hours. Three methods of initial rt-PA delivery will be used: 1) Trellis-8 Peripheral Infusion System - maximum first-session rt-PA dose 25 mg; 2) AngioJet Rheolytic Thrombectomy System - maximum first-session rt-PA dose 25 mg; or 3) Catheter-directed rt-PA infusion for up to 24 hours at 0.01 mg/kg/hr (maximum 1.0 mg/hr) via a multisidehole infusion catheter. Before and after PCDT, patients will receive standard DVT therapy as in the Control Arm

Recombinant tissue plasminogen activator (rt-PA): Pharmacomechanical catheter-directed thrombolysis, consisting of intrathrombus administration of rt-PA using a catheter/device.

Initial anticoagulant therapy with unfractionated heparin, enoxaparin, dalteparin, or tinzaparin, for at least 5 days, overlapped with long-term oral warfarin (target INR 2.0 - 3.0). Elastic compression stockings will be prescribed
Overall Number of Participants Analyzed 317 325
Mean (Standard Error)
Unit of Measure: points
-1.62  (0.10) -1.29  (0.10)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection A-Intervention, B-Control
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.02
Comments [Not Specified]
Method Regression, Linear
Comments Adjusted by extent of thrombus and clinical center
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.33
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.14
Estimation Comments [Not Specified]
25.Secondary Outcome
Title Change in Leg Pain Severity
Hide Description Likert pain scale ranging from 1-7, with higher scores representing a greater intensity of pain
Time Frame Baseline to 30 days post-randomization
Hide Outcome Measure Data
Hide Analysis Population Description
Modified full analysis set; intention to treat
Arm/Group Title A-Intervention B-Control
Hide Arm/Group Description:

PCDT with intrathrombus delivery of rt-PA (maximum allowable total dose 35 mg) into the DVT over a period of up to 24 hours. Three methods of initial rt-PA delivery will be used: 1) Trellis-8 Peripheral Infusion System - maximum first-session rt-PA dose 25 mg; 2) AngioJet Rheolytic Thrombectomy System - maximum first-session rt-PA dose 25 mg; or 3) Catheter-directed rt-PA infusion for up to 24 hours at 0.01 mg/kg/hr (maximum 1.0 mg/hr) via a multisidehole infusion catheter. Before and after PCDT, patients will receive standard DVT therapy as in the Control Arm

Recombinant tissue plasminogen activator (rt-PA): Pharmacomechanical catheter-directed thrombolysis, consisting of intrathrombus administration of rt-PA using a catheter/device.

Initial anticoagulant therapy with unfractionated heparin, enoxaparin, dalteparin, or tinzaparin, for at least 5 days, overlapped with long-term oral warfarin (target INR 2.0 - 3.0). Elastic compression stockings will be prescribed
Overall Number of Participants Analyzed 314 317
Mean (Standard Error)
Unit of Measure: points
-2.17  (0.11) -1.83  (0.11)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection A-Intervention, B-Control
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.03
Comments [Not Specified]
Method Regression, Linear
Comments Adjusted by extent of thrombus and clinical center
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.34
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.15
Estimation Comments [Not Specified]
26.Secondary Outcome
Title Change in Leg Circumference
Hide Description Mean calf circumference measured 10 cm below the tibial tuberosity
Time Frame Baseline to 10 days post-randomization
Hide Outcome Measure Data
Hide Analysis Population Description
Modified full analysis set; intention to treat
Arm/Group Title A-Intervention B-Control
Hide Arm/Group Description:

PCDT with intrathrombus delivery of rt-PA (maximum allowable total dose 35 mg) into the DVT over a period of up to 24 hours. Three methods of initial rt-PA delivery will be used: 1) Trellis-8 Peripheral Infusion System - maximum first-session rt-PA dose 25 mg; 2) AngioJet Rheolytic Thrombectomy System - maximum first-session rt-PA dose 25 mg; or 3) Catheter-directed rt-PA infusion for up to 24 hours at 0.01 mg/kg/hr (maximum 1.0 mg/hr) via a multisidehole infusion catheter. Before and after PCDT, patients will receive standard DVT therapy as in the Control Arm

Recombinant tissue plasminogen activator (rt-PA): Pharmacomechanical catheter-directed thrombolysis, consisting of intrathrombus administration of rt-PA using a catheter/device.

Initial anticoagulant therapy with unfractionated heparin, enoxaparin, dalteparin, or tinzaparin, for at least 5 days, overlapped with long-term oral warfarin (target INR 2.0 - 3.0). Elastic compression stockings will be prescribed
Overall Number of Participants Analyzed 305 323
Mean (Standard Error)
Unit of Measure: centimeters
-0.26  (0.17) 0.27  (0.16)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection A-Intervention, B-Control
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.02
Comments [Not Specified]
Method Regression, Linear
Comments Adjusted by extent of thrombus and clinical center
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.53
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.23
Estimation Comments [Not Specified]
27.Secondary Outcome
Title Change in Leg Circumference
Hide Description Mean calf circumference measured 10 cm below the tibial tuberosity
Time Frame Baseline to 30 days post-randomization
Hide Outcome Measure Data
Hide Analysis Population Description
Modified full analysis set; intention to treat
Arm/Group Title A-Intervention B-Control
Hide Arm/Group Description:

PCDT with intrathrombus delivery of rt-PA (maximum allowable total dose 35 mg) into the DVT over a period of up to 24 hours. Three methods of initial rt-PA delivery will be used: 1) Trellis-8 Peripheral Infusion System - maximum first-session rt-PA dose 25 mg; 2) AngioJet Rheolytic Thrombectomy System - maximum first-session rt-PA dose 25 mg; or 3) Catheter-directed rt-PA infusion for up to 24 hours at 0.01 mg/kg/hr (maximum 1.0 mg/hr) via a multisidehole infusion catheter. Before and after PCDT, patients will receive standard DVT therapy as in the Control Arm

Recombinant tissue plasminogen activator (rt-PA): Pharmacomechanical catheter-directed thrombolysis, consisting of intrathrombus administration of rt-PA using a catheter/device.

Initial anticoagulant therapy with unfractionated heparin, enoxaparin, dalteparin, or tinzaparin, for at least 5 days, overlapped with long-term oral warfarin (target INR 2.0 - 3.0). Elastic compression stockings will be prescribed
Overall Number of Participants Analyzed 304 315
Mean (Standard Error)
Unit of Measure: centimeters
-0.74  (0.17) -0.28  (0.16)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection A-Intervention, B-Control
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.05
Comments [Not Specified]
Method Regression, Linear
Comments Adjusted by extent of thrombus and clinical center
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.46
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.23
Estimation Comments [Not Specified]
Time Frame Serious adverse events were collected throughout the study - i.e. through 24 months post-randomization. Non-serious adverse events were collected through 30 days post-randomization, and through 30 days after any subsequent PCDT procedure.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title A-Intervention B-Control
Hide Arm/Group Description

PCDT with intrathrombus delivery of rt-PA (maximum allowable total dose 35 mg) into the DVT over a period of up to 24 hours. Three methods of initial rt-PA delivery will be used: 1) Trellis-8 Peripheral Infusion System - maximum first-session rt-PA dose 25 mg; 2) AngioJet Rheolytic Thrombectomy System - maximum first-session rt-PA dose 25 mg; or 3) Catheter-directed rt-PA infusion for up to 24 hours at 0.01 mg/kg/hr (maximum 1.0 mg/hr) via a multisidehole infusion catheter. Before and after PCDT, patients will receive standard DVT therapy as in the Control Arm

Recombinant tissue plasminogen activator (rt-PA): Pharmacomechanical catheter-directed thrombolysis, consisting of intrathrombus administration of rt-PA using a catheter/device.

Initial anticoagulant therapy with unfractionated heparin, enoxaparin, dalteparin, or tinzaparin, for at least 5 days, overlapped with long-term oral warfarin (target INR 2.0 - 3.0). Elastic compression stockings will be prescribed
All-Cause Mortality
A-Intervention B-Control
Affected / at Risk (%) Affected / at Risk (%)
Total   7/336 (2.08%)      8/355 (2.25%)    
Show Serious Adverse Events Hide Serious Adverse Events
A-Intervention B-Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   109/336 (32.44%)      86/355 (24.23%)    
Blood and lymphatic system disorders     
Heparin induced thrombocytopenia   3/336 (0.89%)  3 0/355 (0.00%)  0
Leukocytosis   1/336 (0.30%)  1 0/355 (0.00%)  0
Mediastinal adenopathy   1/336 (0.30%)  1 0/355 (0.00%)  0
Cardiac disorders     
Acute CHF with atrial fibrillation and rapid ventricular response   0/336 (0.00%)  0 1/355 (0.28%)  1
Acute coronary syndrome   1/336 (0.30%)  1 0/355 (0.00%)  0
Acute rejection (heart transplant)   1/336 (0.30%)  1 0/355 (0.00%)  0
Aortic insufficiency   0/336 (0.00%)  0 1/355 (0.28%)  1
Arrhythmia   0/336 (0.00%)  0 1/355 (0.28%)  1
Asystole   0/336 (0.00%)  0 1/355 (0.28%)  1
Atrial fibrillation   3/336 (0.89%)  19 4/355 (1.13%)  5
Atrial flutter with rapid ventricular response   0/336 (0.00%)  0 1/355 (0.28%)  1
Atypical chest pain   1/336 (0.30%)  1 2/355 (0.56%)  2
Cardiomyopathy   3/336 (0.89%)  3 0/355 (0.00%)  0
Chest pain and shortness of breath   0/336 (0.00%)  0 3/355 (0.85%)  3
Chest pain, shortness of breath, hemoptysis   0/336 (0.00%)  0 1/355 (0.28%)  1
Congestive heart failure   4/336 (1.19%)  4 2/355 (0.56%)  6
Coronary artery disease   3/336 (0.89%)  3 0/355 (0.00%)  0
Coronary artery disease and hypertension   0/336 (0.00%)  0 1/355 (0.28%)  1
Hypertensive urgency with CHF exacerbation   0/336 (0.00%)  0 1/355 (0.28%)  1
Leg swelling   1/336 (0.30%)  1 1/355 (0.28%)  1
Lightheadedness   1/336 (0.30%)  1 0/355 (0.00%)  0
Non-ST wave myocardial infarction   3/336 (0.89%)  5 0/355 (0.00%)  0
Ear and labyrinth disorders     
Vertigo   0/336 (0.00%)  0 1/355 (0.28%)  1
Endocrine disorders     
Diabetic neuropathy   1/336 (0.30%)  1 0/355 (0.00%)  0
Gastrointestinal disorders     
Abdominal pain   4/336 (1.19%)  6 4/355 (1.13%)  4
Acute gallstone pancreatitis   0/336 (0.00%)  0 1/355 (0.28%)  2
Acute on chronic pancreatitis   1/336 (0.30%)  1 0/355 (0.00%)  0
Acute short bowel obstruction versus Crohn's disease   1/336 (0.30%)  1 0/355 (0.00%)  0
Anemia   2/336 (0.60%)  2 0/355 (0.00%)  0
Antral gastritic   1/336 (0.30%)  1 0/355 (0.00%)  0
Bleeding gums   0/336 (0.00%)  0 1/355 (0.28%)  1
Colitis   1/336 (0.30%)  3 1/355 (0.28%)  1
Death secondary to metastatic gastric carcinoma   1/336 (0.30%)  1 0/355 (0.00%)  0
Diarrhea   1/336 (0.30%)  1 2/355 (0.56%)  2
Diverticulosis   2/336 (0.60%)  2 0/355 (0.00%)  0
Esophageal stricture   1/336 (0.30%)  1 0/355 (0.00%)  0
Gastrointestinal bleed   8/336 (2.38%)  8 6/355 (1.69%)  6
Gastroparesis   1/336 (0.30%)  1 0/355 (0.00%)  0
Intra-abdominal fluid collection   1/336 (0.30%)  1 0/355 (0.00%)  0
Irritable bowel syndrome   0/336 (0.00%)  0 1/355 (0.28%)  1
Nausea and vomiting   0/336 (0.00%)  0 1/355 (0.28%)  1
Nausea, vomiting, diarrhea   2/336 (0.60%)  2 0/355 (0.00%)  0
Obstipation with ileus   0/336 (0.00%)  0 1/355 (0.28%)  1
Small bowel obstruction   1/336 (0.30%)  1 1/355 (0.28%)  1
General disorders     
Chest pain   7/336 (2.08%)  7 10/355 (2.82%)  11
Fever   2/336 (0.60%)  2 0/355 (0.00%)  0
Multisystem organ failure   1/336 (0.30%)  1 0/355 (0.00%)  0
Hepatobiliary disorders     
Biliary diskinesia and sludge   0/336 (0.00%)  0 1/355 (0.28%)  1
Cholangitis   1/336 (0.30%)  1 0/355 (0.00%)  0
Cholecystitis   1/336 (0.30%)  1 2/355 (0.56%)  2
Immune system disorders     
Acute thrombocytopenic purpura   0/336 (0.00%)  0 1/355 (0.28%)  1
Angioedema, unclear etiology   1/336 (0.30%)  3 0/355 (0.00%)  0
Sarcoidosis   1/336 (0.30%)  1 0/355 (0.00%)  0
Serum sickness   1/336 (0.30%)  1 0/355 (0.00%)  0
Infections and infestations     
Abnormal lab results secondary to undetermined infection   1/336 (0.30%)  1 0/355 (0.00%)  0
Acute diverticulitis   0/336 (0.00%)  0 1/355 (0.28%)  2
Acute viral gastroenteritis   0/336 (0.00%)  0 1/355 (0.28%)  1
Bacteremia   1/336 (0.30%)  1 1/355 (0.28%)  1
Bilateral lower extremity cellulitis and CHF   0/336 (0.00%)  0 1/355 (0.28%)  1
Cellulitis   6/336 (1.79%)  7 4/355 (1.13%)  4
Gangrene left hallux   1/336 (0.30%)  1 0/355 (0.00%)  0
Influenza A   0/336 (0.00%)  0 1/355 (0.28%)  1
Intra-abdominal infection   1/336 (0.30%)  2 0/355 (0.00%)  0
Osteomyelitis   2/336 (0.60%)  2 0/355 (0.00%)  0
Perihepatic abscess   1/336 (0.30%)  1 0/355 (0.00%)  0
Pneumonia   3/336 (0.89%)  5 6/355 (1.69%)  6
Post-operative infection   0/336 (0.00%)  0 1/355 (0.28%)  1
Pyelonephritis   1/336 (0.30%)  1 1/355 (0.28%)  1
Right hand abscess   0/336 (0.00%)  0 1/355 (0.28%)  1
Sepsis   0/336 (0.00%)  0 5/355 (1.41%)  6
Sepsis and pneumonia   0/336 (0.00%)  0 1/355 (0.28%)  1
Septic shock   0/336 (0.00%)  0 2/355 (0.56%)  2
Sinusitis   2/336 (0.60%)  2 0/355 (0.00%)  0
Staph infection in right shoulder   1/336 (0.30%)  1 0/355 (0.00%)  0
Suspected infection to stump from right below-knee amputation   0/336 (0.00%)  0 1/355 (0.28%)  1
Viral gastroenteritis   0/336 (0.00%)  0 1/355 (0.28%)  1
Viral syndrome   0/336 (0.00%)  0 1/355 (0.28%)  1
Vomoting and diarrhea   0/336 (0.00%)  0 1/355 (0.28%)  1
Wound abscess   1/336 (0.30%)  1 0/355 (0.00%)  0
Injury, poisoning and procedural complications     
Acute oxycodone and doxylamine intoxication   1/336 (0.30%)  1 0/355 (0.00%)  0
Acute phencyclidine intoxication   1/336 (0.30%)  1 0/355 (0.00%)  0
Alcohol intoxication   2/336 (0.60%)  3 3/355 (0.85%)  3
Broken ribs   0/336 (0.00%)  0 1/355 (0.28%)  1
Disconnected VP shunt   0/336 (0.00%)  0 1/355 (0.28%)  1
Fall after alcohol abuse   0/336 (0.00%)  0 1/355 (0.28%)  1
Fibula fracture   1/336 (0.30%)  1 0/355 (0.00%)  0
Fracture and cellulitis of right first toe   0/336 (0.00%)  0 1/355 (0.28%)  1
Fractured humerus and ribs - fell off ladder   0/336 (0.00%)  0 1/355 (0.28%)  1
Gunshot wound   0/336 (0.00%)  0 1/355 (0.28%)  1
Intra-abdominal fluid collection secondary to bile leak   1/336 (0.30%)  1 0/355 (0.00%)  0
Migrated VP shunt   0/336 (0.00%)  0 1/355 (0.28%)  2
Motor vehicle accident   0/336 (0.00%)  0 1/355 (0.28%)  1
Methicillin-resistant Staphylococcus Aureus - wound   1/336 (0.30%)  1 0/355 (0.00%)  0
Overdose   0/336 (0.00%)  0 1/355 (0.28%)  1
Post-percardiotomy syndrome   1/336 (0.30%)  2 0/355 (0.00%)  0
Right knee tear of medial meniscus   1/336 (0.30%)  1 0/355 (0.00%)  0
Spinal headache   1/336 (0.30%)  1 0/355 (0.00%)  0
Subdural hematoma   2/336 (0.60%)  2 0/355 (0.00%)  0
Ventricular perforation   1/336 (0.30%)  1 0/355 (0.00%)  0
Investigations     
Elevated INR   1/336 (0.30%)  1 2/355 (0.56%)  2
Elevated troponin   0/336 (0.00%)  0 1/355 (0.28%)  1
Low hemoglobin   1/336 (0.30%)  1 0/355 (0.00%)  0
Mania, bizarre behavior, agitation   0/336 (0.00%)  0 1/355 (0.28%)  1
Metabolism and nutrition disorders     
Dehydration   0/336 (0.00%)  0 2/355 (0.56%)  2
Diabetic ketoacidosis   1/336 (0.30%)  1 0/355 (0.00%)  0
Hyperthyroidism   1/336 (0.30%)  1 0/355 (0.00%)  0
Hypoglycemia   1/336 (0.30%)  1 0/355 (0.00%)  0
Lactic acidosis, acute sepsis, atrial fibrillation   1/336 (0.30%)  1 0/355 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Acute costochondritis   0/336 (0.00%)  0 1/355 (0.28%)  1
Back spasm   0/336 (0.00%)  0 1/355 (0.28%)  1
Complex gouty septic olecranon bursitis   1/336 (0.30%)  1 0/355 (0.00%)  0
Flank pain   2/336 (0.60%)  2 1/355 (0.28%)  1
Foot pain/burning   1/336 (0.30%)  1 1/355 (0.28%)  1
Herniated lumbar disc   1/336 (0.30%)  1 1/355 (0.28%)  1
Hip fracture   0/336 (0.00%)  0 2/355 (0.56%)  2
Left C4-C5 neuroforaminal stenosis   1/336 (0.30%)  1 0/355 (0.00%)  0
Left lower extremity pain and abscess   0/336 (0.00%)  0 1/355 (0.28%)  1
Leg pain   2/336 (0.60%)  2 3/355 (0.85%)  3
Leg pain and swelling   0/336 (0.00%)  0 1/355 (0.28%)  2
Severe bilateral knee degenerative joint disease   1/336 (0.30%)  1 0/355 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Adenocarcinoma of unknown primary   1/336 (0.30%)  1 0/355 (0.00%)  0
Breast cancer   1/336 (0.30%)  1 0/355 (0.00%)  0
Breast intraductal papilloma   0/336 (0.00%)  0 1/355 (0.28%)  1
Colon cancer - adenocarcinoma   0/336 (0.00%)  0 1/355 (0.28%)  1
Gastric adenocarcinoma   1/336 (0.30%)  1 0/355 (0.00%)  0
Kidney cancer   1/336 (0.30%)  1 0/355 (0.00%)  0
Lymphoma   0/336 (0.00%)  0 1/355 (0.28%)  2
Metastatic adenocarcinoma   0/336 (0.00%)  0 1/355 (0.28%)  1
Ovarian cancer   1/336 (0.30%)  1 0/355 (0.00%)  0
Pancreatic cancer   0/336 (0.00%)  0 1/355 (0.28%)  2
Papillary thyroid cancer   0/336 (0.00%)  0 1/355 (0.28%)  1
Prostate cancer   2/336 (0.60%)  2 0/355 (0.00%)  0
Squamous cell carcinoma of unknown primary   1/336 (0.30%)  1 0/355 (0.00%)  0
Surgical excision of squamous cell carcinoma   1/336 (0.30%)  1 0/355 (0.00%)  0
Nervous system disorders     
Acute and progressive cauda equina syndrome   0/336 (0.00%)  0 1/355 (0.28%)  1
Acute encephalopathy   0/336 (0.00%)  0 1/355 (0.28%)  1
Blurred vision and diffuse itching   1/336 (0.30%)  1 0/355 (0.00%)  0
C5 on C6 retrolisthesia   1/336 (0.30%)  1 0/355 (0.00%)  0
Intracranial hemorrhage   0/336 (0.00%)  0 1/355 (0.28%)  1
Massive closed head injury   1/336 (0.30%)  1 0/355 (0.00%)  0
Reversible cerebral vasoconstriction syndrome   0/336 (0.00%)  0 1/355 (0.28%)  1
Seizure   3/336 (0.89%)  3 1/355 (0.28%)  1
Stroke   6/336 (1.79%)  6 0/355 (0.00%)  0
Syncope   1/336 (0.30%)  1 5/355 (1.41%)  6
Transient dysarthria   1/336 (0.30%)  1 0/355 (0.00%)  0
Transient ischemia attack   0/336 (0.00%)  0 1/355 (0.28%)  1
Psychiatric disorders     
Alcohol Withdrawal   3/336 (0.89%)  4 0/355 (0.00%)  0
Altered mental state   0/336 (0.00%)  0 1/355 (0.28%)  1
Bipolar disorder   0/336 (0.00%)  0 1/355 (0.28%)  1
Depression   1/336 (0.30%)  1 3/355 (0.85%)  3
Short-term memory impairment of uncertain etiology   0/336 (0.00%)  0 1/355 (0.28%)  1
Suicidal ideation   0/336 (0.00%)  0 1/355 (0.28%)  6
Suicidal ideation and alcohol withdrawal   0/336 (0.00%)  0 1/355 (0.28%)  2
Suicide attempt   0/336 (0.00%)  0 1/355 (0.28%)  1
Renal and urinary disorders     
Acute renal failure   5/336 (1.49%)  7 1/355 (0.28%)  4
Diabetic nephropathy   0/336 (0.00%)  0 1/355 (0.28%)  1
Hematuria   2/336 (0.60%)  2 2/355 (0.56%)  2
Hemorrhagic cystitis   1/336 (0.30%)  1 0/355 (0.00%)  0
Obstructing ureteral stone   0/336 (0.00%)  0 1/355 (0.28%)  1
Renal vein obstruction   1/336 (0.30%)  1 0/355 (0.00%)  0
Urinary tract infection   1/336 (0.30%)  1 1/355 (0.28%)  1
Urinary tract infection and cellulitis   0/336 (0.00%)  0 1/355 (0.28%)  1
Reproductive system and breast disorders     
Ruptured ovarian cyst   1/336 (0.30%)  1 0/355 (0.00%)  0
Uterine bleeding   0/336 (0.00%)  0 2/355 (0.56%)  2
Uterine cancer   1/336 (0.30%)  1 0/355 (0.00%)  0
Vaginal bleeding   1/336 (0.30%)  1 0/355 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Acute on chronic respiratory insufficiency   1/336 (0.30%)  1 0/355 (0.00%)  0
Aspiration pneumonia   1/336 (0.30%)  1 0/355 (0.00%)  0
Asthma exacerbation   1/336 (0.30%)  1 1/355 (0.28%)  1
Bronchitis   0/336 (0.00%)  0 1/355 (0.28%)  3
Chest pain/asthma exacerbation   0/336 (0.00%)  0 1/355 (0.28%)  2
Chronic obstructive pulmonary disease   3/336 (0.89%)  3 5/355 (1.41%)  8
Cough   0/336 (0.00%)  0 1/355 (0.28%)  1
Dyspnea   1/336 (0.30%)  1 0/355 (0.00%)  0
Dyspnea with lower extremity edema   0/336 (0.00%)  0 1/355 (0.28%)  1
Epistaxis   0/336 (0.00%)  0 1/355 (0.28%)  1
Hemoptysis   0/336 (0.00%)  0 1/355 (0.28%)  1
Hypoxia due to hypoventilation due to multiple pain medications   1/336 (0.30%)  1 0/355 (0.00%)  0
Metastatic lung cancer   0/336 (0.00%)  0 1/355 (0.28%)  2
Pleural effusion   1/336 (0.30%)  2 0/355 (0.00%)  0
Pleuritic chest pain   1/336 (0.30%)  1 1/355 (0.28%)  1
Pneumonia and pulmonary hypertension likely due to PE   1/336 (0.30%)  1 0/355 (0.00%)  0
Pulmonary edema   0/336 (0.00%)  0 1/355 (0.28%)  1
Pulmonary embolism   10/336 (2.98%)  12 7/355 (1.97%)  9
Respiratory failure   0/336 (0.00%)  0 1/355 (0.28%)  1
Skin and subcutaneous tissue disorders     
Intertigo labialis   0/336 (0.00%)  0 1/355 (0.28%)  1
Surgical and medical procedures     
Debridement of right below-the-knee amputation   0/336 (0.00%)  0 1/355 (0.28%)  1
Degenerative joint disease with total right hip replacement   1/336 (0.30%)  1 0/355 (0.00%)  0
Left hip removal of hardware and total hip arthoplasty   1/336 (0.30%)  1 0/355 (0.00%)  0
Right foot amputation   1/336 (0.30%)  1 0/355 (0.00%)  0
Vascular disorders     
Acute arterial limb ischemia of left lower extremity   1/336 (0.30%)  1 0/355 (0.00%)  0
Acute right lower extremity DVT and acute bronchitis   0/336 (0.00%)  0 1/355 (0.28%)  1
Arterial occlusion   0/336 (0.00%)  0 1/355 (0.28%)  1
Bleeding at sheath puncture site   1/336 (0.30%)  1 0/355 (0.00%)  0
Bleeding from wound   0/336 (0.00%)  0 1/355 (0.28%)  1
DVT and PE   3/336 (0.89%)  3 2/355 (0.56%)  2
Hemoperitoneum of unknown etiology   1/336 (0.30%)  1 0/355 (0.00%)  0
Hemorrhagic shock   1/336 (0.30%)  1 0/355 (0.00%)  0
Hypertensive urgency   0/336 (0.00%)  0 1/355 (0.28%)  1
Hypovolemic shocck   0/336 (0.00%)  0 1/355 (0.28%)  1
Orthostatic hyptension secondary to beta blockers and dehydration   0/336 (0.00%)  0 1/355 (0.28%)  1
Peripheral arterial disease   0/336 (0.00%)  0 1/355 (0.28%)  1
Deep vein thrombosis   25/336 (7.44%)  36 17/355 (4.79%)  20
Right knee hematoma   0/336 (0.00%)  0 1/355 (0.28%)  1
Syncope and head contusion   0/336 (0.00%)  0 1/355 (0.28%)  1
Type A ascending aortic dissection   0/336 (0.00%)  0 1/355 (0.28%)  1
Venous thromboembolism   0/336 (0.00%)  0 1/355 (0.28%)  1
Retroperitoneal bleed   2/336 (0.60%)  2 1/355 (0.28%)  1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
A-Intervention B-Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/336 (0.00%)      0/355 (0.00%)    
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Suresh Vedantham, Principal Investigator
Organization: Washington University in St. Louis
Phone: 3143622900 ext 314
EMail: vedanthams@mir.wustl.edu
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00790335     History of Changes
Other Study ID Numbers: 22326953211
U01HL088476-01A1 ( U.S. NIH Grant/Contract )
First Submitted: October 15, 2008
First Posted: November 13, 2008
Results First Submitted: December 18, 2017
Results First Posted: March 29, 2018
Last Update Posted: March 29, 2018