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VIRTUS: An Evaluation of the Vici™ Venous Stent System in Patients With Chronic Iliofemoral Venous Outflow Obstruction (VIRTUS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02112877
Recruitment Status : Active, not recruiting
First Posted : April 14, 2014
Results First Posted : July 30, 2019
Last Update Posted : July 8, 2020
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Sequential Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Chronic Venous Disorder
Venous Outflow Obstruction
Symptomatic Venous Outflow Obstruction of Iliofemoral Vein
Intervention Device: Veniti Vici™ Venous Stent System
Enrollment 200
Recruitment Details  
Pre-assignment Details A total of 200 subjects have been enrolled in the VIRTUS Trial, including 30 subjects in the feasibility cohort and 170 subjects in the pivotal cohort.
Arm/Group Title VICI Stent Implantation - Feasibility VICI Stent Implantation - Pivotal
Hide Arm/Group Description

Percutaneous stent placement in the common femoral vein, external iliac vein and/or common iliac vein

Veniti Vici™ Venous Stent System

Percutaneous stent placement in the common femoral vein, external iliac vein and/or common iliac vein

Veniti Vici™ Venous Stent System

Period Title: Overall Study
Started 30 170
Completed 28 157
Not Completed 2 13
Reason Not Completed
Withdrawal by Subject             1             7
Visit Missed             1             6
Arm/Group Title VICI Stent Implantation - Feasibility VICI Stent Implantation - Pivotal Total
Hide Arm/Group Description

Percutaneous stent placement in the common femoral vein, external iliac vein and/or common iliac vein

Veniti Vici™ Venous Stent System

Percutaneous stent placement in the common femoral vein, external iliac vein and/or common iliac vein

Veniti Vici™ Venous Stent System

Total of all reporting groups
Overall Number of Baseline Participants 30 170 200
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 30 participants 170 participants 200 participants
44.4  (14.3) 54.4  (16.2) 52.9  (16.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 170 participants 200 participants
Female
24
  80.0%
96
  56.5%
120
  60.0%
Male
6
  20.0%
74
  43.5%
80
  40.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
American Indian or Alaska Native Number Analyzed 30 participants 170 participants 200 participants
0
   0.0%
1
   0.6%
1
   0.5%
Asian Number Analyzed 30 participants 170 participants 200 participants
2
   6.7%
5
   2.9%
7
   3.5%
Black or African American Number Analyzed 30 participants 170 participants 200 participants
1
   3.3%
20
  11.8%
21
  10.5%
Native Hawaiian or Pacific Islander Number Analyzed 30 participants 170 participants 200 participants
0
   0.0%
1
   0.6%
1
   0.5%
White Number Analyzed 30 participants 170 participants 200 participants
25
  83.3%
127
  74.7%
152
  76.0%
White African Number Analyzed 30 participants 170 participants 200 participants
0
   0.0%
1
   0.6%
1
   0.5%
Latin American Number Analyzed 30 participants 170 participants 200 participants
0
   0.0%
1
   0.6%
1
   0.5%
Not Answered Number Analyzed 30 participants 170 participants 200 participants
0
   0.0%
14
   8.2%
14
   7.0%
North African Number Analyzed 30 participants 170 participants 200 participants
2
   6.7%
0
   0.0%
2
   1.0%
Race/Ethnicity, Customized   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Hispanic or Latino Number Analyzed 27 participants 154 participants 181 participants
2
   7.4%
13
   8.4%
15
   8.3%
Not Hispanic or Latino Number Analyzed 27 participants 154 participants 181 participants
25
  92.6%
141
  91.6%
166
  91.7%
[1]
Measure Analysis Population Description: For the feasibility cohort, ethnicity data has been provided by 27/30 subjects. For the pivotal cohort, 16 subjects from the sites located in France did not provide their ethnicity per the policy at each site.
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Netherlands Number Analyzed 30 participants 170 participants 200 participants
1
   3.3%
0
   0.0%
1
   0.5%
United States Number Analyzed 30 participants 170 participants 200 participants
8
  26.7%
119
  70.0%
127
  63.5%
Ireland Number Analyzed 30 participants 170 participants 200 participants
3
  10.0%
5
   2.9%
8
   4.0%
United Kingdom Number Analyzed 30 participants 170 participants 200 participants
10
  33.3%
22
  12.9%
32
  16.0%
France Number Analyzed 30 participants 170 participants 200 participants
3
  10.0%
18
  10.6%
21
  10.5%
Germany Number Analyzed 30 participants 170 participants 200 participants
0
   0.0%
5
   2.9%
5
   2.5%
Spain Number Analyzed 30 participants 170 participants 200 participants
5
  16.7%
1
   0.6%
6
   3.0%
Chronic Non-Malignant Obstruction  
Measure Type: Count of Participants
Unit of measure:  Participants
Left Leg Number Analyzed 30 participants 170 participants 200 participants
24
  80.0%
145
  85.3%
169
  84.5%
Right Leg Number Analyzed 30 participants 170 participants 200 participants
5
  16.7%
24
  14.1%
29
  14.5%
Both Legs Number Analyzed 30 participants 170 participants 200 participants
1
   3.3%
1
   0.6%
2
   1.0%
Clinical Etiology Anatomy Pathophysiology (CEAP) Assessment  
Measure Type: Count of Participants
Unit of measure:  Participants
0 (No visible or palpable signs of venous disease Number Analyzed 30 participants 170 participants 200 participants
1
   3.3%
2
   1.2%
3
   1.5%
1 (Telangiectasia or reticular veins) Number Analyzed 30 participants 170 participants 200 participants
0
   0.0%
0
   0.0%
0
   0.0%
2 (Varicose Veins) Number Analyzed 30 participants 170 participants 200 participants
0
   0.0%
2
   1.2%
2
   1.0%
3 (Edema) Number Analyzed 30 participants 170 participants 200 participants
13
  43.3%
45
  26.5%
58
  29.0%
4 (Skin changes ascribed to venous disease) Number Analyzed 30 participants 170 participants 200 participants
13
  43.3%
78
  45.9%
91
  45.5%
5 (Healed ulceration) Number Analyzed 30 participants 170 participants 200 participants
2
   6.7%
22
  12.9%
24
  12.0%
6 (Active ulceration) Number Analyzed 30 participants 170 participants 200 participants
1
   3.3%
21
  12.4%
22
  11.0%
Venous Clinical Severity Score (VCSS) Leg Pain (Target Limb)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Absent Number Analyzed 30 participants 146 participants 176 participants
2
   6.7%
15
  10.3%
17
   9.7%
Mild Number Analyzed 30 participants 146 participants 176 participants
2
   6.7%
35
  24.0%
37
  21.0%
Moderate Number Analyzed 30 participants 146 participants 176 participants
17
  56.7%
54
  37.0%
71
  40.3%
Severe Number Analyzed 30 participants 146 participants 176 participants
9
  30.0%
42
  28.8%
51
  29.0%
[1]
Measure Analysis Population Description: For the pivotal cohort, results for 24 subjects from a single US center are not included due to data integrity issues.
Diabetic  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 170 participants 200 participants
2
   6.7%
29
  17.1%
31
  15.5%
Smoking History  
Measure Type: Count of Participants
Unit of measure:  Participants
Current Smoker Number Analyzed 30 participants 170 participants 200 participants
3
  10.0%
21
  12.4%
24
  12.0%
Former Smoker Number Analyzed 30 participants 170 participants 200 participants
8
  26.7%
41
  24.1%
49
  24.5%
Non-Smoker Number Analyzed 30 participants 170 participants 200 participants
19
  63.3%
108
  63.5%
127
  63.5%
History of Pulmonary Embolism (PE)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 130 participants 149 participants
2
  10.5%
28
  21.5%
30
  20.1%
[1]
Measure Analysis Population Description: For the feasibility cohort, only 19 subjects were initially classified as having a history of thromboembolic disease. For the pivotal cohort, only 130 subjects were initially classified as having a history of thromboembolic disease.
History of Deep Vein Thrombosis (DVT)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 130 participants 149 participants
19
 100.0%
119
  91.5%
138
  92.6%
[1]
Measure Analysis Population Description: For the feasibility cohort, only 19 subjects were initially classified as having a history of thromboembolic disease. For the pivotal cohort, only 130 subjects were initially classified as having a history of thromboembolic disease.
History of Coronary Artery Disease (CAD)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 170 participants 200 participants
0
   0.0%
14
   8.2%
14
   7.0%
History of Myocardial Infarction (MI) within past 5 years  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 170 participants 200 participants
0
   0.0%
1
   0.6%
1
   0.5%
History of Coronary Artery Bypass Grafting (CABG)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 170 participants 200 participants
0
   0.0%
4
   2.4%
4
   2.0%
History of Percutaneous Transluminal Coronary Angioplasty (PTCA)/Stent  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 170 participants 200 participants
0
   0.0%
4
   2.4%
4
   2.0%
History of Congestive Heart Failure (CHF)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 170 participants 200 participants
0
   0.0%
4
   2.4%
4
   2.0%
History of Hypertension (HTN)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 170 participants 200 participants
7
  23.3%
68
  40.0%
75
  37.5%
History of Hepatic Disease  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 170 participants 200 participants
1
   3.3%
5
   2.9%
6
   3.0%
History of Renal Disease  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 170 participants 200 participants
1
   3.3%
8
   4.7%
9
   4.5%
History of Peripheral Vascular Disease (PVD)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 170 participants 200 participants
2
   6.7%
29
  17.1%
31
  15.5%
History of Coagulation Disorder  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 170 participants 200 participants
7
  23.3%
23
  13.5%
30
  15.0%
History of Cerebrovascular Accident (CVA)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 170 participants 200 participants
1
   3.3%
10
   5.9%
11
   5.5%
History of Cancer  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 170 participants 200 participants
2
   6.7%
18
  10.6%
20
  10.0%
History of Recent Trauma  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 170 participants 200 participants
1
   3.3%
3
   1.8%
4
   2.0%
History of Allergies  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 170 participants 200 participants
4
  13.3%
60
  35.3%
64
  32.0%
1.Primary Outcome
Title Number of Participants With Major Adverse Events (MAE)
Hide Description The primary safety endpoint for this study will be a composite endpoint of any major adverse event (MAE) within 30 days, as adjudicated by a Clinical Events Committee.
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
For the pivotal cohort, one subject never returned for follow-up after discharge.
Arm/Group Title VICI Stent Implantation - Feasibility VICI Stent Implantation - Pivotal
Hide Arm/Group Description:

Percutaneous stent placement in the common femoral vein, external iliac vein and/or common iliac vein

Veniti Vici™ Venous Stent System

Percutaneous stent placement in the common femoral vein, external iliac vein and/or common iliac vein

Veniti Vici™ Venous Stent System

Overall Number of Participants Analyzed 30 169
Measure Type: Count of Participants
Unit of Measure: Participants
Device or procedure-related death
0
   0.0%
0
   0.0%
Device or procedure-related bleeding
0
   0.0%
0
   0.0%
Device or procedure-related arterial/venous injury
2
   6.7%
2
   1.2%
Device or procedure-related acuteDeepVeinThrombus
0
   0.0%
0
   0.0%
Clinically significant pulmonary embolism
0
   0.0%
0
   0.0%
Embolization of the stent
0
   0.0%
0
   0.0%
2.Primary Outcome
Title Percentage of Participants That Demonstrated Primary Patency
Hide Description The primary effectiveness endpoint is the primary patency rate at 12 months post-intervention, defined as freedom from occlusion by thrombosis, freedom from surgical or endovascular intervention on target vessel which are found to have re-stenosis or stent occlusion to maintain patency, and freedom from in-stent stenosis more than 50% by venogram.
Time Frame 12 months post-intervention
Hide Outcome Measure Data
Hide Analysis Population Description
For the feasibility cohort, month 12 outcomes were available for 22 subjects. For the pivotal cohort, month 12 outcomes were available for 125 subjects. Those without venography performed at 12 months had their result assigned by random selection from subjects with a venogram result who had the same anatomy and the same DUS outcome (if available).
Arm/Group Title VICI Stent Implantation - Feasibility VICI Stent Implantation - Pivotal
Hide Arm/Group Description:

Percutaneous stent placement in the common femoral vein, external iliac vein and/or common iliac vein

Veniti Vici™ Venous Stent System

Percutaneous stent placement in the common femoral vein, external iliac vein and/or common iliac vein

Veniti Vici™ Venous Stent System

Overall Number of Participants Analyzed 22 170
Measure Type: Number
Unit of Measure: Percentage of Participants
77.3 84.0
3.Secondary Outcome
Title Number of Participants With Improvement in Venous Clinical Severity Score (VCSS)
Hide Description The secondary effectiveness endpoint for this study will be a binary response variable based on an improvement in Venous Clinical Severity Score (VCSS) by at least 50% at 12 months post-intervention. VCSS measures 10 clinical attributes of venous disease (Pain, Varicose Veins, Venous Edema, Skin Pigmentation, Inflammation, Induration, No. Active Ulcers, Active Ulcer Size, Ulcer Duration and Compression Therapy) on a scale of 0 - 3 (Absent 0, Mild 1, Moderate 2, and Severe 3).
Time Frame 12 months post-intervention
Hide Outcome Measure Data
Hide Analysis Population Description
For the feasibility cohort, 7 subjects did not have VCSS results at both month 12 and baseline. For the pivotal cohort, results for 24 subjects from a single US center are not included due to data integrity issues and 14 subjects did not have VCSS results at both month 12 and Baseline.
Arm/Group Title VICI Stent Implantation - Feasibility VICI Stent Implantation - Pivotal
Hide Arm/Group Description:

Percutaneous stent placement in the common femoral vein, external iliac vein and/or common iliac vein

Veniti Vici™ Venous Stent System

Percutaneous stent placement in the common femoral vein, external iliac vein and/or common iliac vein

Veniti Vici™ Venous Stent System

Overall Number of Participants Analyzed 23 132
Measure Type: Count of Participants
Unit of Measure: Participants
13
  56.5%
65
  49.2%
4.Other Pre-specified Outcome
Title Number of Participants With Procedural Technical Success
Hide Description Procedural technical success is achievement of a final residual target vessel diameter stenosis of ≤50% as measured on the post procedural venogram, without skipped lesion regions, with placement of the study device alone with or without post-stenting balloon dilation as needed.
Time Frame During Procedure
Hide Outcome Measure Data
Hide Analysis Population Description
For the pivotal cohort, four subjects did not have the post-procedural venogram available for assessment. Additionally, there were two subjects that failed the endpoint due to two investigators using non-study stents.
Arm/Group Title VICI Stent Implantation - Feasibility VICI Stent Implantation - Pivotal
Hide Arm/Group Description:

Percutaneous stent placement in the common femoral vein, external iliac vein and/or common iliac vein

Veniti Vici™ Venous Stent System

Percutaneous stent placement in the common femoral vein, external iliac vein and/or common iliac vein

Veniti Vici™ Venous Stent System

Overall Number of Participants Analyzed 30 166
Measure Type: Count of Participants
Unit of Measure: Participants
30
 100.0%
164
  98.8%
5.Other Pre-specified Outcome
Title Number of Participants With Lesion Success
Hide Description Lesion success is defined as achievement of ≤50% residual diameter stenosis of the target lesion using any percutaneous method (including the use of non-study devices).
Time Frame During Procedure
Hide Outcome Measure Data
Hide Analysis Population Description
For the pivotal cohort, four subjects did not have the post-procedural veogram available for assessment.
Arm/Group Title VICI Stent Implantation - Feasibility VICI Stent Implantation - Pivotal
Hide Arm/Group Description:

Percutaneous stent placement in the common femoral vein, external iliac vein and/or common iliac vein

Veniti Vici™ Venous Stent System

Percutaneous stent placement in the common femoral vein, external iliac vein and/or common iliac vein

Veniti Vici™ Venous Stent System

Overall Number of Participants Analyzed 30 166
Measure Type: Count of Participants
Unit of Measure: Participants
30
 100.0%
166
 100.0%
6.Other Pre-specified Outcome
Title Number of Participants With Procedural Success
Hide Description Procedural success is defined as procedural technical success without the occurrence of a major adverse event (MAE) between the index procedure and discharge.
Time Frame From the time of the Index Procedure post procedural venogram through the time of Index Procedure Discharge or 3 days Post-Procedure (whichever comes first)
Hide Outcome Measure Data
Hide Analysis Population Description
For the pivotal cohort, four subjects did not have the post-procedural venogram available for assessment.
Arm/Group Title VICI Stent Implantation - Feasibility VICI Stent Implantation - Pivotal
Hide Arm/Group Description:

Percutaneous stent placement in the common femoral vein, external iliac vein and/or common iliac vein

Veniti Vici™ Venous Stent System

Percutaneous stent placement in the common femoral vein, external iliac vein and/or common iliac vein

Veniti Vici™ Venous Stent System

Overall Number of Participants Analyzed 30 166
Measure Type: Count of Participants
Unit of Measure: Participants
28
  93.3%
162
  97.6%
7.Other Pre-specified Outcome
Title Number of Participants With Late Technical Success
Hide Description Late technical success (through 12 months) is the absence of device movement >10mm related to anatomical landmarks or any migration leading to symptoms or requiring therapy; absence of stent occlusion by thrombosis or restenosis, defined as reduction in treated segment lumen more than 50% from the post-procedure vessel lumen diameter as measured by post-procedural venogram or DUS and maintenance of structural integrity, defined as the absence of pinching (focal compression), kinking (stent doubling or bending upon itself) that results in >50% diameter reduction of the stent, recoil (poor radial resistive force) or absence of fractures .
Time Frame 12 months post-intervention
Hide Outcome Measure Data
Hide Analysis Population Description
For the feasibility cohort, month 12 outcomes were available for 22 subjects. For the pivotal cohort, only 127 subjects had a 12-month venogram and/or stent fracture assessment.
Arm/Group Title VICI Stent Implantation - Feasibility VICI Stent Implantation - Pivotal
Hide Arm/Group Description:

Percutaneous stent placement in the common femoral vein, external iliac vein and/or common iliac vein

Veniti Vici™ Venous Stent System

Percutaneous stent placement in the common femoral vein, external iliac vein and/or common iliac vein

Veniti Vici™ Venous Stent System

Overall Number of Participants Analyzed 22 127
Measure Type: Count of Participants
Unit of Measure: Participants
16
  72.7%
97
  76.4%
8.Other Pre-specified Outcome
Title Change in the Quality of Life (Chronic Venous Insufficiency Questionnaire)(CIVIQ2))
Hide Description The overall change in CIVIQ2 scores for the study patients, calculated using the mean scores at baseline and 12-months. This instrument is scored from 20 to 100 points with lower scores indicating a lesser impact on health.
Time Frame Baseline and 12 months post-intervention
Hide Outcome Measure Data
Hide Analysis Population Description
For the feasibility cohort, three subjects did not have Month 12 CIVIQ-2 results. For the pivotal cohort, results for 24 subjects from a single US center are not included due to data integrity issues. Also, 11 subjects did not have a Month 12 visit and 2 subjects did not complete the CIVIQ forms.
Arm/Group Title VICI Stent Implantation - Feasibility VICI Stent Implantation - Pivotal
Hide Arm/Group Description:

Percutaneous stent placement in the common femoral vein, external iliac vein and/or common iliac vein

Veniti Vici™ Venous Stent System

Percutaneous stent placement in the common femoral vein, external iliac vein and/or common iliac vein

Veniti Vici™ Venous Stent System

Overall Number of Participants Analyzed 27 133
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-15.4
(-22.1 to -8.6)
-13.1
(-16.3 to -10.0)
9.Other Pre-specified Outcome
Title Number of Participants With Estimated Primary-Assisted Patency
Hide Description Primary-assisted patency is defined as freedom from occlusion regardless of whether an intervention (subsequent to the index procedure) was performed.
Time Frame 12 months post-intervention
Hide Outcome Measure Data
Hide Analysis Population Description
For the feasibility cohort, only 21 subjects had known outcomes. For the pivotal cohort, only 126 subjects had known outcomes.
Arm/Group Title VICI Stent Implantation - Feasibility VICI Stent Implantation - Pivotal
Hide Arm/Group Description:

Percutaneous stent placement in the common femoral vein, external iliac vein and/or common iliac vein

Veniti Vici™ Venous Stent System

Percutaneous stent placement in the common femoral vein, external iliac vein and/or common iliac vein

Veniti Vici™ Venous Stent System

Overall Number of Participants Analyzed 21 126
Measure Type: Count of Participants
Unit of Measure: Participants
20
  95.2%
117
  92.9%
10.Other Pre-specified Outcome
Title Number of Participants With Estimated Secondary Patency
Hide Description Secondary patency is defined as freedom from "permanent" loss of patency determined through last follow-up (irrespective of the number of interventions).
Time Frame 36 months post-intervention
Outcome Measure Data Not Reported
Time Frame Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title VICI Stent Implantation - Feasibility VICI Stent Implantation - Pivotal
Hide Arm/Group Description

Percutaneous stent placement in the common femoral vein, external iliac vein and/or common iliac vein

Veniti Vici™ Venous Stent System

Percutaneous stent placement in the common femoral vein, external iliac vein and/or common iliac vein

Veniti Vici™ Venous Stent System

All-Cause Mortality
VICI Stent Implantation - Feasibility VICI Stent Implantation - Pivotal
Affected / at Risk (%) Affected / at Risk (%)
Total   0/30 (0.00%)      0/170 (0.00%)    
Hide Serious Adverse Events
VICI Stent Implantation - Feasibility VICI Stent Implantation - Pivotal
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   11/30 (36.67%)      59/170 (34.71%)    
Blood and lymphatic system disorders     
Anaemia   0/30 (0.00%)  0 1/170 (0.59%)  1
Sickle cell anaemia with crisis   0/30 (0.00%)  0 1/170 (0.59%)  1
Thrombocytopenia   0/30 (0.00%)  0 1/170 (0.59%)  1
Haemorrhagic anaemia   0/30 (0.00%)  0 1/170 (0.59%)  1
White blood cell disorder   0/30 (0.00%)  0 1/170 (0.59%)  1
Cardiac disorders     
Acute myocardial infarction   0/30 (0.00%)  0 2/170 (1.18%)  2
Bradycardia   0/30 (0.00%)  0 1/170 (0.59%)  1
Cardiac failure congestive   0/30 (0.00%)  0 1/170 (0.59%)  1
Pericardial effusion   0/30 (0.00%)  0 1/170 (0.59%)  1
Ventricular tachycardia   0/30 (0.00%)  0 1/170 (0.59%)  1
Atrial fibrillation   0/30 (0.00%)  0 1/170 (0.59%)  3
Gastrointestinal disorders     
Internal hernia   1/30 (3.33%)  1 0/170 (0.00%)  0
Gastric perforation   0/30 (0.00%)  0 1/170 (0.59%)  1
Ileus   0/30 (0.00%)  0 1/170 (0.59%)  1
Melaena   0/30 (0.00%)  0 1/170 (0.59%)  1
Rectal haemorrhage   0/30 (0.00%)  0 1/170 (0.59%)  1
General disorders     
Vascular stent thrombosis   3/30 (10.00%)  4 9/170 (5.29%)  13
Vascular stent restenosis   2/30 (6.67%)  2 3/170 (1.76%)  3
Vascular stent stenosis   1/30 (3.33%)  1 2/170 (1.18%)  2
Vascular stent occlusion   1/30 (3.33%)  1 2/170 (1.18%)  2
Stenosis   0/30 (0.00%)  0 1/170 (0.59%)  1
Oedema peripheral   0/30 (0.00%)  0 1/170 (0.59%)  1
Peripheral swelling   0/30 (0.00%)  0 1/170 (0.59%)  1
Puncture site haemorrhage   0/30 (0.00%)  0 1/170 (0.59%)  1
Hepatobiliary disorders     
Cholelithiasis   1/30 (3.33%)  1 0/170 (0.00%)  0
Infections and infestations     
Sepsis   0/30 (0.00%)  0 3/170 (1.76%)  3
Urinary tract infection   0/30 (0.00%)  0 1/170 (0.59%)  1
Cellulitis   0/30 (0.00%)  0 1/170 (0.59%)  1
Parotitis   0/30 (0.00%)  0 1/170 (0.59%)  1
Injury, poisoning and procedural complications     
Vascular pseudoaneurysm   1/30 (3.33%)  1 0/170 (0.00%)  0
Vascular access site hemorrhage   1/30 (3.33%)  1 0/170 (0.00%)  0
Vascular access site hematoma   1/30 (3.33%)  1 0/170 (0.00%)  0
Vascular pseudoaneurysm ruptured   0/30 (0.00%)  0 1/170 (0.59%)  1
Hip fracture   0/30 (0.00%)  0 1/170 (0.59%)  1
Wound   0/30 (0.00%)  0 1/170 (0.59%)  1
Post procedural haematoma   0/30 (0.00%)  0 1/170 (0.59%)  1
Delayed haemolytic transfusion reaction   0/30 (0.00%)  0 1/170 (0.59%)  1
Investigations     
International normalized ratio decreased   1/30 (3.33%)  1 0/170 (0.00%)  0
Blood culture positive   0/30 (0.00%)  0 1/170 (0.59%)  1
Haemoglobin decreased   0/30 (0.00%)  0 1/170 (0.59%)  1
Specific gravity urine abnormal   0/30 (0.00%)  0 1/170 (0.59%)  1
Metabolism and nutrition disorders     
Diabetic ketoacidosis   0/30 (0.00%)  0 1/170 (0.59%)  1
Musculoskeletal and connective tissue disorders     
Back pain   0/30 (0.00%)  0 3/170 (1.76%)  3
Pain in extremity   0/30 (0.00%)  0 2/170 (1.18%)  2
Rhabdomyolysis   0/30 (0.00%)  0 1/170 (0.59%)  1
Arthralgia   0/30 (0.00%)  0 1/170 (0.59%)  1
Nervous system disorders     
Sciatica   0/30 (0.00%)  0 1/170 (0.59%)  1
Seizure   0/30 (0.00%)  0 2/170 (1.18%)  2
Cerebral haemorrhage   0/30 (0.00%)  0 1/170 (0.59%)  1
Cerebrovascular accident   0/30 (0.00%)  0 1/170 (0.59%)  1
Encephalopathy   0/30 (0.00%)  0 1/170 (0.59%)  1
Encephalomalacia   0/30 (0.00%)  0 1/170 (0.59%)  1
Product Issues     
Stent malfunction   2/30 (6.67%)  2 2/170 (1.18%)  2
Device malfunction   1/30 (3.33%)  1 0/170 (0.00%)  0
Device dislocation   1/30 (3.33%)  1 3/170 (1.76%)  3
Device occlusion   0/30 (0.00%)  0 1/170 (0.59%)  1
Psychiatric disorders     
Mental status changes   0/30 (0.00%)  0 1/170 (0.59%)  1
Renal and urinary disorders     
Renal vein compression   1/30 (3.33%)  1 0/170 (0.00%)  0
Chronic kidney disease   0/30 (0.00%)  0 1/170 (0.59%)  1
Acute kidney injury   0/30 (0.00%)  0 2/170 (1.18%)  2
Respiratory, thoracic and mediastinal disorders     
Asthma   1/30 (3.33%)  1 0/170 (0.00%)  0
Pulmonary embolism   0/30 (0.00%)  0 2/170 (1.18%)  2
Respiratory depression   0/30 (0.00%)  0 1/170 (0.59%)  1
Respiratory failure   0/30 (0.00%)  0 1/170 (0.59%)  1
Skin and subcutaneous tissue disorders     
Skin ulcer   0/30 (0.00%)  0 2/170 (1.18%)  2
Surgical and medical procedures     
Venous angioplasty   3/30 (10.00%)  5 7/170 (4.12%)  8
Venous stent insertion   2/30 (6.67%)  2 1/170 (0.59%)  1
Hysterectomy   1/30 (3.33%)  1 0/170 (0.00%)  0
Thrombolysis   0/30 (0.00%)  0 4/170 (2.35%)  4
Vascular stent insertion   0/30 (0.00%)  0 2/170 (1.18%)  2
Angioplasty   0/30 (0.00%)  0 1/170 (0.59%)  1
Thrombectomy   0/30 (0.00%)  0 1/170 (0.59%)  1
Varicose vein operation   0/30 (0.00%)  0 4/170 (2.35%)  4
Hip arthroplasty   0/30 (0.00%)  0 1/170 (0.59%)  1
Myomectomy   0/30 (0.00%)  0 1/170 (0.59%)  1
Hernia repair   0/30 (0.00%)  0 1/170 (0.59%)  1
Transfusion   0/30 (0.00%)  0 1/170 (0.59%)  1
Interventional procedure   0/30 (0.00%)  0 1/170 (0.59%)  1
Cholecystectomy   0/30 (0.00%)  0 1/170 (0.59%)  1
Vascular disorders     
Arteriovenous fistula   1/30 (3.33%)  1 2/170 (1.18%)  2
Varicose vein   1/30 (3.33%)  1 1/170 (0.59%)  1
Aneurysm ruptured   1/30 (3.33%)  1 0/170 (0.00%)  0
Deep vein thrombosis   1/30 (3.33%)  1 10/170 (5.88%)  12
Vena cava thrombosis   0/30 (0.00%)  0 1/170 (0.59%)  1
Venous stenosis   0/30 (0.00%)  0 1/170 (0.59%)  1
Venous occlusion   0/30 (0.00%)  0 1/170 (0.59%)  1
Aortic aneurysm   0/30 (0.00%)  0 1/170 (0.59%)  1
Varicose ulceration   0/30 (0.00%)  0 1/170 (0.59%)  1
Vascular compression   0/30 (0.00%)  0 1/170 (0.59%)  1
Peripheral venous disease   0/30 (0.00%)  0 1/170 (0.59%)  1
Phlebitis   0/30 (0.00%)  0 1/170 (0.59%)  2
Paget-Schroetter syndrome   0/30 (0.00%)  0 1/170 (0.59%)  1
Venous thrombosis   0/30 (0.00%)  0 1/170 (0.59%)  1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
VICI Stent Implantation - Feasibility VICI Stent Implantation - Pivotal
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   14/30 (46.67%)      102/170 (60.00%)    
Blood and lymphatic system disorders     
Antiphospholipid syndrome   1/30 (3.33%)  1 0/170 (0.00%)  0
Anaemia   0/30 (0.00%)  0 2/170 (1.18%)  2
Lymphadenopathy   0/30 (0.00%)  0 1/170 (0.59%)  1
Cardiac disorders     
Bradycardia   1/30 (3.33%)  1 0/170 (0.00%)  0
Palpitations   0/30 (0.00%)  0 1/170 (0.59%)  1
Cyanosis   0/30 (0.00%)  0 1/170 (0.59%)  1
Endocrine disorders     
Thyroid mass   0/30 (0.00%)  0 1/170 (0.59%)  1
Eye disorders     
Vision blurred   1/30 (3.33%)  1 0/170 (0.00%)  0
Blindness   0/30 (0.00%)  0 1/170 (0.59%)  1
Gastrointestinal disorders     
Abdominal distension   1/30 (3.33%)  1 0/170 (0.00%)  0
Nausea   1/30 (3.33%)  1 4/170 (2.35%)  4
Abdominal pain   0/30 (0.00%)  0 5/170 (2.94%)  5
Vomiting   0/30 (0.00%)  0 2/170 (1.18%)  2
Ascites   0/30 (0.00%)  0 1/170 (0.59%)  1
Crohn's disease   0/30 (0.00%)  0 1/170 (0.59%)  1
Diarrhaea haemorrhagic   0/30 (0.00%)  0 1/170 (0.59%)  1
Gastritis   0/30 (0.00%)  0 1/170 (0.59%)  1
Gastrointestinal haemorrhage   0/30 (0.00%)  0 1/170 (0.59%)  1
Bile acid malabsorption   0/30 (0.00%)  0 1/170 (0.59%)  1
Mouth haemorrhage   0/30 (0.00%)  0 1/170 (0.59%)  1
General disorders     
Hypothermia   1/30 (3.33%)  1 0/170 (0.00%)  0
Tenderness   1/30 (3.33%)  1 0/170 (0.00%)  0
Adverse drug reaction   1/30 (3.33%)  1 0/170 (0.00%)  0
Non-cardiac chest pain   1/30 (3.33%)  1 1/170 (0.59%)  1
Vascular stent thrombosis   1/30 (3.33%)  1 5/170 (2.94%)  5
Complication associated with device   1/30 (3.33%)  1 0/170 (0.00%)  0
Peripheral swelling   0/30 (0.00%)  0 16/170 (9.41%)  17
Chest pain   0/30 (0.00%)  0 2/170 (1.18%)  2
Oedema peripheral   0/30 (0.00%)  0 3/170 (1.76%)  3
Chills   0/30 (0.00%)  0 1/170 (0.59%)  1
Facial pain   0/30 (0.00%)  0 1/170 (0.59%)  1
Fatigue   0/30 (0.00%)  0 1/170 (0.59%)  1
Influenza like illness   0/30 (0.00%)  0 1/170 (0.59%)  1
Injection site bruising   0/30 (0.00%)  0 1/170 (0.59%)  1
Injection site pain   0/30 (0.00%)  0 1/170 (0.59%)  1
Oedema   0/30 (0.00%)  0 1/170 (0.59%)  1
Pain   0/30 (0.00%)  0 2/170 (1.18%)  2
Vascular stent occlusion   0/30 (0.00%)  0 3/170 (1.76%)  3
Puncture site hemorrhage   0/30 (0.00%)  0 1/170 (0.59%)  1
Vascular stent stenosis   0/30 (0.00%)  0 2/170 (1.18%)  2
Localized oedema   0/30 (0.00%)  0 1/170 (0.59%)  1
Vascular stent restenosis   0/30 (0.00%)  0 1/170 (0.59%)  1
Hepatobiliary disorders     
Hepatitis   0/30 (0.00%)  0 1/170 (0.59%)  1
Immune system disorders     
Drug hypersensitivity   0/30 (0.00%)  0 3/170 (1.76%)  3
Infections and infestations     
Lower respiratory tract infection   1/30 (3.33%)  1 0/170 (0.00%)  0
Pharyngitis   1/30 (3.33%)  1 0/170 (0.00%)  0
Infected skin ulcer   0/30 (0.00%)  0 2/170 (1.18%)  2
Pneumonia   0/30 (0.00%)  0 2/170 (1.18%)  2
Cellulitis   0/30 (0.00%)  0 1/170 (0.59%)  1
Parotitis   0/30 (0.00%)  0 1/170 (0.59%)  1
Postoperative wound infection   0/30 (0.00%)  0 1/170 (0.59%)  1
Sepsis   0/30 (0.00%)  0 1/170 (0.59%)  1
Tinea cruris   0/30 (0.00%)  0 1/170 (0.59%)  1
Infected cyst   0/30 (0.00%)  0 1/170 (0.59%)  1
Respiratory tract infection   0/30 (0.00%)  0 1/170 (0.59%)  1
Infected varicose vein   0/30 (0.00%)  0 1/170 (0.59%)  2
Urinary tract infection   0/30 (0.00%)  0 2/170 (1.18%)  2
Fungal skin infection   0/30 (0.00%)  0 1/170 (0.59%)  1
Root canal infection   0/30 (0.00%)  0 1/170 (0.59%)  1
Injury, poisoning and procedural complications     
Fall   1/30 (3.33%)  1 3/170 (1.76%)  3
Laceration   1/30 (3.33%)  1 0/170 (0.00%)  0
Peripheral nerve injury   1/30 (3.33%)  1 0/170 (0.00%)  0
Contusion   1/30 (3.33%)  1 0/170 (0.00%)  0
Thermal burn   1/30 (3.33%)  1 0/170 (0.00%)  0
Post procedural hematoma   1/30 (3.33%)  1 0/170 (0.00%)  0
Foot fracture   0/30 (0.00%)  0 1/170 (0.59%)  1
Hand fracture   0/30 (0.00%)  0 2/170 (1.18%)  2
Hip fracture   0/30 (0.00%)  0 1/170 (0.59%)  1
Ligament sprain   0/30 (0.00%)  0 1/170 (0.59%)  1
Tendon rupture   0/30 (0.00%)  0 1/170 (0.59%)  1
Procedural headache   0/30 (0.00%)  0 1/170 (0.59%)  1
Vascular access site haemorrhage   0/30 (0.00%)  0 2/170 (1.18%)  2
Humerus fracture   0/30 (0.00%)  0 1/170 (0.59%)  1
Post procedural constipation   0/30 (0.00%)  0 1/170 (0.59%)  1
Vascular access site hemorrhage   0/30 (0.00%)  0 1/170 (0.59%)  1
Vascular access site pain   0/30 (0.00%)  0 1/170 (0.59%)  1
Investigations     
Hemoglobin decreased   1/30 (3.33%)  1 0/170 (0.00%)  0
Oxygen saturation decreased   1/30 (3.33%)  1 1/170 (0.59%)  1
Weight increased   1/30 (3.33%)  1 1/170 (0.59%)  1
Antiphospholipid antibodies positive   1/30 (3.33%)  1 0/170 (0.00%)  0
Blood creatinine increased   0/30 (0.00%)  0 1/170 (0.59%)  1
International normalised ratio increased   0/30 (0.00%)  0 1/170 (0.59%)  1
Nuclear magnetic resonance imaging brain abnormal   0/30 (0.00%)  0 1/170 (0.59%)  1
Venous pressure increased   0/30 (0.00%)  0 1/170 (0.59%)  1
Cyst aspiration   0/30 (0.00%)  0 1/170 (0.59%)  1
Metabolism and nutrition disorders     
Dehydration   1/30 (3.33%)  1 1/170 (0.59%)  1
Hyponatremia   1/30 (3.33%)  1 0/170 (0.00%)  0
Hyperglycaemia   0/30 (0.00%)  0 2/170 (1.18%)  2
Hyperkalaemia   0/30 (0.00%)  0 1/170 (0.59%)  1
Hyperglycemia   0/30 (0.00%)  0 1/170 (0.59%)  1
Musculoskeletal and connective tissue disorders     
Muscle spasms   2/30 (6.67%)  2 0/170 (0.00%)  0
Back pain   2/30 (6.67%)  3 15/170 (8.82%)  16
Pain in extremity   2/30 (6.67%)  3 17/170 (10.00%)  21
Costochondritis   1/30 (3.33%)  1 0/170 (0.00%)  0
Groin pain   1/30 (3.33%)  1 2/170 (1.18%)  2
Tendon pain   1/30 (3.33%)  1 0/170 (0.00%)  0
Arthralgia   0/30 (0.00%)  0 5/170 (2.94%)  5
Musculoskeletal chest pain   0/30 (0.00%)  0 1/170 (0.59%)  1
Osteoarthritis   0/30 (0.00%)  0 3/170 (1.76%)  3
Osteoporotic fracture   0/30 (0.00%)  0 1/170 (0.59%)  1
Rheumatoid arthritis   0/30 (0.00%)  0 1/170 (0.59%)  1
Synovial cyst   0/30 (0.00%)  0 1/170 (0.59%)  1
Limb discomfort   0/30 (0.00%)  0 1/170 (0.59%)  1
Joint range of motion decreased   0/30 (0.00%)  0 1/170 (0.59%)  1
Musculoskeletal pain   0/30 (0.00%)  0 2/170 (1.18%)  2
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Basal cell carcinoma   0/30 (0.00%)  0 1/170 (0.59%)  1
Benign breast neoplasm   0/30 (0.00%)  0 1/170 (0.59%)  1
Melanocytic naevus   0/30 (0.00%)  0 1/170 (0.59%)  1
Prostate cancer   0/30 (0.00%)  0 1/170 (0.59%)  1
Nervous system disorders     
Lethargy   1/30 (3.33%)  1 0/170 (0.00%)  0
Paraesthesia   1/30 (3.33%)  1 3/170 (1.76%)  3
Syncope   1/30 (3.33%)  1 1/170 (0.59%)  1
Dizziness   0/30 (0.00%)  0 2/170 (1.18%)  2
Headache   0/30 (0.00%)  0 2/170 (1.18%)  2
Amnesia   0/30 (0.00%)  0 1/170 (0.59%)  1
Burning sensation   0/30 (0.00%)  0 1/170 (0.59%)  1
Carotid artery aneurysm   0/30 (0.00%)  0 1/170 (0.59%)  1
Facial paralysis   0/30 (0.00%)  0 1/170 (0.59%)  1
Loss of consciousness   0/30 (0.00%)  0 1/170 (0.59%)  1
Seizure   0/30 (0.00%)  0 1/170 (0.59%)  1
VIth nerve paralysis   0/30 (0.00%)  0 1/170 (0.59%)  1
Pregnancy, puerperium and perinatal conditions     
Blighted ovum   0/30 (0.00%)  0 1/170 (0.59%)  1
Product Issues     
Device dislocation   0/30 (0.00%)  0 1/170 (0.59%)  1
Stent malfunction   0/30 (0.00%)  0 1/170 (0.59%)  1
Psychiatric disorders     
Phonophobia   0/30 (0.00%)  0 1/170 (0.59%)  1
Drug use disorder   0/30 (0.00%)  0 2/170 (1.18%)  7
Anxiety   0/30 (0.00%)  0 1/170 (0.59%)  1
Renal and urinary disorders     
Haematuria   0/30 (0.00%)  0 3/170 (1.76%)  3
Nephrolithiasis   0/30 (0.00%)  0 2/170 (1.18%)  2
Renal cyst   0/30 (0.00%)  0 1/170 (0.59%)  1
Acute kidney injury   0/30 (0.00%)  0 2/170 (1.18%)  2
Reproductive system and breast disorders     
Vaginal haemorrhage   0/30 (0.00%)  0 1/170 (0.59%)  1
Pelvic congestion   0/30 (0.00%)  0 1/170 (0.59%)  2
Menorrhagia   0/30 (0.00%)  0 1/170 (0.59%)  1
Scrotal pain   0/30 (0.00%)  0 1/170 (0.59%)  1
Respiratory, thoracic and mediastinal disorders     
Bronchiectasis   1/30 (3.33%)  1 0/170 (0.00%)  0
Epistaxis   1/30 (3.33%)  1 3/170 (1.76%)  3
Productive cough   1/30 (3.33%)  1 0/170 (0.00%)  0
Pulmonary embolism   1/30 (3.33%)  1 0/170 (0.00%)  0
Dyspnaea   0/30 (0.00%)  0 3/170 (1.76%)  4
Atelectasis   0/30 (0.00%)  0 1/170 (0.59%)  1
Cough   0/30 (0.00%)  0 1/170 (0.59%)  2
Haemoptysis   0/30 (0.00%)  0 2/170 (1.18%)  2
Pulmonary congestion   0/30 (0.00%)  0 1/170 (0.59%)  1
Respiratory distress   0/30 (0.00%)  0 1/170 (0.59%)  1
Bronchospasm   0/30 (0.00%)  0 1/170 (0.59%)  1
Dyspnoea exertional   0/30 (0.00%)  0 1/170 (0.59%)  1
Skin and subcutaneous tissue disorders     
Skin ulcer   0/30 (0.00%)  0 3/170 (1.76%)  4
Alopecia   0/30 (0.00%)  0 1/170 (0.59%)  1
Blister   0/30 (0.00%)  0 1/170 (0.59%)  1
Decubitus ulcer   0/30 (0.00%)  0 1/170 (0.59%)  1
Dermatitis contact   0/30 (0.00%)  0 1/170 (0.59%)  1
Hyperhidrosis   0/30 (0.00%)  0 1/170 (0.59%)  2
Rash   0/30 (0.00%)  0 2/170 (1.18%)  3
Skin discolouration   0/30 (0.00%)  0 2/170 (1.18%)  3
Rash pruritic   0/30 (0.00%)  0 1/170 (0.59%)  1
Social circumstances     
Homeless   0/30 (0.00%)  0 1/170 (0.59%)  1
Surgical and medical procedures     
Abortion induced   1/30 (3.33%)  1 0/170 (0.00%)  0
Venous angioplasty   0/30 (0.00%)  0 3/170 (1.76%)  3
Thrombolysis   0/30 (0.00%)  0 2/170 (1.18%)  2
Varicose vein operation   0/30 (0.00%)  0 2/170 (1.18%)  2
Joint fluid drainage   0/30 (0.00%)  0 1/170 (0.59%)  1
Vena cava filter insertion   0/30 (0.00%)  0 1/170 (0.59%)  2
Vena cava filter removal   0/30 (0.00%)  0 1/170 (0.59%)  2
Vascular stent insertion   0/30 (0.00%)  0 1/170 (0.59%)  1
Venous stent insertion   0/30 (0.00%)  0 1/170 (0.59%)  1
Varicose vein   0/30 (0.00%)  0 2/170 (1.18%)  2
Vascular disorders     
Hyperemia   1/30 (3.33%)  1 0/170 (0.00%)  0
Hypotension   1/30 (3.33%)  1 2/170 (1.18%)  2
Thrombosis   1/30 (3.33%)  1 1/170 (0.59%)  1
Hematoma   0/30 (0.00%)  0 2/170 (1.18%)  2
Haematoma   0/30 (0.00%)  0 1/170 (0.59%)  1
Deep vein thrombosis   0/30 (0.00%)  0 2/170 (1.18%)  2
Peripheral coldness   0/30 (0.00%)  0 1/170 (0.59%)  1
Hemorrhage   0/30 (0.00%)  0 1/170 (0.59%)  1
Peripheral venous disease   0/30 (0.00%)  0 16/170 (9.41%)  25
Phlebitis   0/30 (0.00%)  0 2/170 (1.18%)  2
Axillary vein thrombosis   0/30 (0.00%)  0 1/170 (0.59%)  1
Hypertension   0/30 (0.00%)  0 2/170 (1.18%)  2
Lymphoedema   0/30 (0.00%)  0 1/170 (0.59%)  1
Thrombophlebitis superficial   0/30 (0.00%)  0 1/170 (0.59%)  1
Vasculitis   0/30 (0.00%)  0 1/170 (0.59%)  1
Post thrombotic syndrome   0/30 (0.00%)  0 1/170 (0.59%)  1
Subclavian vein thrombosis   0/30 (0.00%)  0 1/170 (0.59%)  1
Peripheral arterial occlusive disease   0/30 (0.00%)  0 1/170 (0.59%)  1
Varicose ulceration   0/30 (0.00%)  0 1/170 (0.59%)  2
Vascular insufficiency   0/30 (0.00%)  0 1/170 (0.59%)  1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Clayton Miller, Sr. Clinical Trial Manager
Organization: Boston Scientific
Phone: 763-494-2512
EMail: clayton.miller@bsci.com
Layout table for additonal information
Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT02112877    
Other Study ID Numbers: STE-HUM-004P
STE-HUM-007P ( Other Identifier: Sponsor )
First Submitted: April 10, 2014
First Posted: April 14, 2014
Results First Submitted: May 24, 2019
Results First Posted: July 30, 2019
Last Update Posted: July 8, 2020