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ABRE Clinical Study of the Abre Venous Self-expanding Stent System

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: NCT03038438
Recruitment Status : Active, not recruiting
First Posted : January 31, 2017
Results First Posted : March 8, 2021
Last Update Posted : March 8, 2021
Sponsor:
Information provided by (Responsible Party):
Medtronic Endovascular

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Iliofemoral Venous Obstruction
Intervention Device: Abre venous self-expanding stent system
Enrollment 260
Recruitment Details Patients were screened for enrollment based on the study Inclusion/Exclusion criteria between December 2017 and November 2018. Included subjects went on to have one or more Abre stents implanted. The first subject was included on December 19, 2017 and the last subject was included on November 29, 2018.
Pre-assignment Details Of the 260 enrolled subjects, 200 met inclusion criteria and were implanted with the Abre stent(s).
Arm/Group Title ABRE
Hide Arm/Group Description Subjects implanted with one or more Abre stents.
Period Title: Overall Study
Started 200
30-Day Follow-Up 198
6-Month Follow-up 193
12-Month Follow-up 191
Completed 196
Not Completed 4
Reason Not Completed
Death             2
Lost to Follow-up             1
Subject Incarcerated             1
Arm/Group Title ABRE
Hide Arm/Group Description Subjects included and implanted with one or more Abre stents
Overall Number of Baseline Participants 200
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 200 participants
51.5  (15.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 200 participants
Female
133
  66.5%
Male
67
  33.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 200 participants
Hispanic or Latino
14
   7.0%
Not Hispanic or Latino
160
  80.0%
Unknown or Not Reported
26
  13.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 200 participants
American Indian or Alaska Native
0
   0.0%
Asian
4
   2.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
17
   8.5%
White
157
  78.5%
More than one race
0
   0.0%
Unknown or Not Reported
22
  11.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 200 participants
United States 128
Ireland 5
United Kingdom 28
Italy 6
France 22
Germany 11
Body Mass Index (BMI)  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 200 participants
29.5  (7.1)
1.Primary Outcome
Title Percentage of Participants With Primary Patency
Hide Description Freedom from occlusion of the stented segment; freedom from restenosis >=50%; and Freedom from clinically-driven target lesion revascularization
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects evaluable for the primary effectiveness endpoint.
Arm/Group Title ABRE
Hide Arm/Group Description:
Subjects implanted with one or more Abre stents.
Overall Number of Participants Analyzed 184
Measure Type: Count of Participants
Unit of Measure: Participants
162
  88.0%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ABRE
Comments

The primary effectiveness endpoint, primary patency at 12 months, was tested against a PG of 75%. The null and alternative hypotheses tested appear below:

H0: π ≤ PG vs. HA: π > PG where π is the primary patency rate at 12 months in the study population and PG is the performance goal of 75%. The primary effectiveness objective will be met if the lower limit of the 97.5% one-sided confidence interval is above 75%.

Type of Statistical Test Other
Comments Single arm study with a hypothesis test comparing to performance goal
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter proportion
Estimated Value 88.0
Confidence Interval (1-Sided) 97.5%
82.5
Estimation Comments [Not Specified]
2.Primary Outcome
Title Percentage of Participants With Composite Major Adverse Events
Hide Description

The components of the Major Adverse Events include:

All-cause death occurring post-procedure, clinically-significant pulmonary embolism, major bleeding complication, stent thrombosis, and stent migration

Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ABRE
Hide Arm/Group Description:
Subjects implanted with one or more Abre stents.
Overall Number of Participants Analyzed 200
Measure Type: Count of Participants
Unit of Measure: Participants
4
   2.0%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ABRE
Comments

The primary safety endpoint, major adverse events at 30 days post-procedure, was tested against a performance goal of 12.5%. The null and alternative hypotheses tested appear below:

H0: P ≥ PG vs. HA: P < PG where P is the primary safety endpoint at 30 days in the study population and PG is the performance goal.

The primary safety objective will be met if the upper limit of the 97.5% one-sided confidence interval is below 12.5%.

Type of Statistical Test Other
Comments Single-arm study with a hypothesis test comparing to performance goal
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter proportion
Estimated Value 2.0
Confidence Interval (1-Sided) 97.5%
5.0
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Device Success
Hide Description Successful delivery and deployment of the stent and removal of the delivery system during the index procedure. Stent based outcome measure.
Time Frame Index Procedure
Hide Outcome Measure Data
Hide Analysis Population Description
302 Abre stents were implanted in 200 included subjects.
Arm/Group Title ABRE
Hide Arm/Group Description:
Subjects implanted with one or more Abre stents.
Overall Number of Participants Analyzed 200
Overall Number of Units Analyzed
Type of Units Analyzed: Implanted Stents
302
Count of Units
Unit of Measure: Implanted Stents
302
 100.0%
4.Secondary Outcome
Title Lesion Success Obtained at Index Procedure
Hide Description Venographic evidence of <50% residual stenosis of the stented segment of the target lesion after post-dilation.
Time Frame Index Procedure
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ABRE
Hide Arm/Group Description:
Subjects implanted with one or more Abre stents.
Overall Number of Participants Analyzed 200
Measure Type: Count of Participants
Unit of Measure: Participants
200
 100.0%
5.Secondary Outcome
Title Index Procedure Success
Hide Description Lesion success without procedure-related MAEs prior to hospital discharge
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ABRE
Hide Arm/Group Description:
Subjects implanted with one or more Abre stents.
Overall Number of Participants Analyzed 200
Measure Type: Count of Participants
Unit of Measure: Participants
198
  99.0%
6.Secondary Outcome
Title Subjects With Primary Assisted Patency at 12 Months
Hide Description Primary assisted patency is defined as uninterrupted patency of the stented segment of the target lesion with a secondary intervention.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable subjects
Arm/Group Title ABRE
Hide Arm/Group Description:
Subjects implanted with one or more Abre stents.
Overall Number of Participants Analyzed 184
Measure Type: Count of Participants
Unit of Measure: Participants
169
  91.8%
7.Secondary Outcome
Title Subjects With Secondary Patency at 12 Months
Hide Description Secondary patency is defined as patency of the stented segment of the target lesion after subsequent intervention for an occlusion.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable subjects
Arm/Group Title ABRE
Hide Arm/Group Description:
Subjects implanted with one or more Abre stents.
Overall Number of Participants Analyzed 184
Measure Type: Count of Participants
Unit of Measure: Participants
171
  92.9%
8.Secondary Outcome
Title Target Lesion Revascularization Through 30 Days, 6-, 12 Months
Hide Description [Not Specified]
Time Frame 30 days, 6 months, and 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Included subjects with an event or a minimum number of follow-up days per time point.
Arm/Group Title ABRE
Hide Arm/Group Description:
Subjects implanted with one or more Abre stents.
Overall Number of Participants Analyzed 200
Measure Type: Count of Participants
Unit of Measure: Participants
30 Days Number Analyzed 200 participants
6
   3.0%
6 Months Number Analyzed 199 participants
15
   7.5%
12 Months Number Analyzed 196 participants
22
  11.2%
9.Secondary Outcome
Title Target Lesion Revascularization Through 24 Months
Hide Description [Not Specified]
Time Frame 24 Month
Outcome Measure Data Not Reported
10.Secondary Outcome
Title Target Lesion Revascularization Through 36 Months
Hide Description [Not Specified]
Time Frame 36 Month
Outcome Measure Data Not Reported
11.Secondary Outcome
Title Major Adverse Events Through 30 Days, 6-, 12 Months
Hide Description [Not Specified]
Time Frame 30 days, 6 months, and 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Included subjects with an event or a minimum number of follow-up days per time point.
Arm/Group Title ABRE
Hide Arm/Group Description:
Subjects implanted with one or more Abre stents.
Overall Number of Participants Analyzed 200
Measure Type: Count of Participants
Unit of Measure: Participants
Within 30 Days Number Analyzed 200 participants
4
   2.0%
Within 6 Months Number Analyzed 200 participants
9
   4.5%
Within 12 Months Number Analyzed 197 participants
12
   6.1%
12.Secondary Outcome
Title Major Adverse Events Through 24 Months
Hide Description [Not Specified]
Time Frame 24 Month
Outcome Measure Data Not Reported
13.Secondary Outcome
Title Major Adverse Events Through 36 Months
Hide Description [Not Specified]
Time Frame 36 Month
Outcome Measure Data Not Reported
14.Secondary Outcome
Title Delayed Stent Migration at 12 Months
Hide Description [Not Specified]
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Included subjects who had scheduled visit-based evaluable imaging and unscheduled imaging up to day 420
Arm/Group Title ABRE
Hide Arm/Group Description:
Subjects implanted with one or more Abre stents.
Overall Number of Participants Analyzed 181
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
15.Secondary Outcome
Title Delayed Stent Migration at 24 Months
Hide Description [Not Specified]
Time Frame 24 Month
Outcome Measure Data Not Reported
16.Secondary Outcome
Title Delayed Stent Migration at 36 Months
Hide Description [Not Specified]
Time Frame 36 Month
Outcome Measure Data Not Reported
17.Secondary Outcome
Title Stent Fracture at 30 Days, 12 Months
Hide Description [Not Specified]
Time Frame 30 days (30 subjects) and 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
X-ray for the 30-day visit was only required on the first 30 subjects; included subjects who had scheduled visit-based evaluable imaging and unscheduled imaging up to day 420.
Arm/Group Title ABRE
Hide Arm/Group Description:
Subjects implanted with one or more Abre stents.
Overall Number of Participants Analyzed 200
Measure Type: Count of Participants
Unit of Measure: Participants
30-Day Number Analyzed 30 participants
0
   0.0%
12-Months Number Analyzed 180 participants
0
   0.0%
18.Secondary Outcome
Title Stent Fracture at 24 Months
Hide Description [Not Specified]
Time Frame 24 Month
Outcome Measure Data Not Reported
19.Secondary Outcome
Title Stent Fracture at 36 Months
Hide Description [Not Specified]
Time Frame 36 Month
Outcome Measure Data Not Reported
20.Secondary Outcome
Title Change in Venous Insufficiency Epidemiological and Economic Study - Quality of Life/Symptoms QOL/Sym Score at 6-, 12 Months
Hide Description Venous Insufficiency Epidemiological and Economic Study - Quality of Life/Symptoms (VEINES QOL/Sym). Higher scores correlate to better quality of life on a scale of 1-100. Change in VEINES QOL/Sym scores were calculated as the Baseline score minus the Follow-up score (6 or 12 months). A positive change is associated with improved outcome.
Time Frame Baseline to 6 and 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects with available data at time point.
Arm/Group Title ABRE
Hide Arm/Group Description:
Subjects implanted with one or more Abre stents.
Overall Number of Participants Analyzed 192
Mean (Standard Deviation)
Unit of Measure: score on a scale
VEINES QoL change from Baseline to 6 Months 22.2  (25.3)
VEINES QoL change from Baseline to 12 Months 22.9  (25.1)
VEINES Sym change from Baseline to 6 months 22.3  (23.6)
VEINES Sym change from Baseline to 12 months 20.9  (24.0)
21.Secondary Outcome
Title Change in Venous Insufficiency Epidemiological and Economic Study - Quality of Life/Symptoms QOL/Sym Score at 24 Months
Hide Description Venous Insufficiency Epidemiological and Economic Study - Quality of Life/Symptoms (VEINES QOL/Sym). Higher scores correlate to better quality of life on a scale of 1-100. Change in VEINES QOL/Sym scores were calculated as the Baseline score minus the Follow-up score (24 months). A positive change is associated with improved outcome.
Time Frame 24 Month
Outcome Measure Data Not Reported
22.Secondary Outcome
Title Change in Venous Insufficiency Epidemiological and Economic Study - Quality of Life/Symptoms QOL/Sym Score at 36 Months
Hide Description Venous Insufficiency Epidemiological and Economic Study - Quality of Life/Symptoms (VEINES QOL/Sym). Higher scores correlate to better quality of life on a scale of 1-100. Change in VEINES QOL/Sym scores were calculated as the Baseline score minus the Follow-up score (36 months). A positive change is associated with improved outcome.
Time Frame 36 Month
Outcome Measure Data Not Reported
23.Secondary Outcome
Title Change in Villalta Score at 6-, 12 Months Compared to Baseline
Hide Description Villalta scores categorize the severity of post-thrombotic syndrome (PTS). Higher score indicates increasing severity of PTS. A score of greater or equal to 5 indicates PTS. PTS severity: total score of 5 to 9, mild PTS; score of 10 to 14, moderate PTS; and score of greater or equal to 15 or venous ulcer present, severe PTS. Change in Villalta scores were calculated as the Baseline score minus the Follow-up score (6 or 12 months). A negative change is associated with improved outcome.
Time Frame Baseline to 6 and 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects with available data at time point
Arm/Group Title ABRE
Hide Arm/Group Description:
Subjects implanted with one or more Abre stents.
Overall Number of Participants Analyzed 200
Mean (Standard Deviation)
Unit of Measure: score on a scale
Change from Baseline to 6 Months Number Analyzed 190 participants
-6.4  (5.4)
Change from Baseline to 12 Months Number Analyzed 191 participants
-7.0  (5.6)
24.Secondary Outcome
Title Change in Villalta Score at 24 Months Compared to Baseline
Hide Description Villalta scores categorize the severity of post-thrombotic syndrome (PTS). Higher score indicates increasing severity of PTS. A score of greater or equal to 5 indicates PTS. PTS severity: total score of 5 to 9, mild PTS; score of 10 to 14, moderate PTS; and score of greater or equal to 15 or venous ulcer present, severe PTS. Change in Villalta scores were calculated as the Baseline score minus the Follow-up score (24 months). A negative change is associated with improved outcome.
Time Frame 24 Month
Outcome Measure Data Not Reported
25.Secondary Outcome
Title Change in Villalta Score at 36 Months Compared to Baseline
Hide Description Villalta scores categorize the severity of post-thrombotic syndrome (PTS). Higher score indicates increasing severity of PTS. A score of greater or equal to 5 indicates PTS. PTS severity: total score of 5 to 9, mild PTS; score of 10 to 14, moderate PTS; and score of greater or equal to 15 or venous ulcer present, severe PTS. Change in Villalta scores were calculated as the Baseline score minus the Follow-up score (36 months). A negative change is associated with improved outcome.
Time Frame 36 Month
Outcome Measure Data Not Reported
26.Secondary Outcome
Title Change in EuroQol-5 Dimension (EQ-5D) Score at 6-, 12 Months Compared to Baseline
Hide Description Higher score indicates a better quality of life. The questionnaire contains five dimensions where scores rank from 1 (best) to 5 (worst) plus a visual analog scale (VAS) (0 = worst health; 100 = best health). A positive change is associated with improved outcome. Change in EQ-5D scores were calculated as the Baseline score minus the Follow-up score (6 or 12 months) for both the index and VAS scores.
Time Frame Baseline to 6 and 12 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects with available data at time point.
Arm/Group Title ABRE
Hide Arm/Group Description:
Subjects implanted with one or more Abre stents.
Overall Number of Participants Analyzed 200
Mean (Standard Deviation)
Unit of Measure: score on a scale
EQ-5D Index Score change from Baseline to 6 Months Number Analyzed 192 participants
0.15  (0.23)
EQ-5D Index Score change from Baseline to 12 Months Number Analyzed 192 participants
0.14  (0.26)
EQ-5D VAS change from baseline to 6 Months Number Analyzed 192 participants
9.3  (22.0)
EQ-5D VAS change from baseline to 12 Months Number Analyzed 191 participants
8.6  (23.1)
27.Secondary Outcome
Title Change in EuroQol-5 Dimension (EQ-5D) Score at 24 Months Compared to Baseline
Hide Description Higher score indicates a better quality of life. The questionnaire contains five dimensions where scores rank from 1 (best) to 5 (worst) plus a visual analog scale (VAS) (0 = worst health; 100 = best health). A positive change is associated with improved outcome. Change in EQ-5D scores were calculated as the Baseline score minus the Follow-up score (24 months) for both the index and VAS scores.
Time Frame 24 Month
Outcome Measure Data Not Reported
28.Secondary Outcome
Title Change in EuroQol-5 Dimension (EQ-5D) Score at 36 Months Compared to Baseline
Hide Description Higher score indicates a better quality of life. The questionnaire contains five dimensions where scores rank from 1 (best) to 5 (worst) plus a visual analog scale (VAS) (0 = worst health; 100 = best health). A positive change is associated with improved outcome. Change in EQ-5D scores were calculated as the Baseline score minus the Follow-up score (36 months) for both the index and VAS scores.
Time Frame 36 Month
Outcome Measure Data Not Reported
29.Secondary Outcome
Title Change in Venous Clinical Severity Score (VCSS) at 6-, and 12 Months Compared to Baseline
Hide Description VCSS scores range from 0=no disease to 30=severe disease. Change in VCSS score was calculated as the Baseline score minus the Follow-up score (6 or 12 months). A negative change is associated with improved outcome.
Time Frame Baseline to 6 and 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects with available data at time point.
Arm/Group Title ABRE
Hide Arm/Group Description:
Subjects implanted with one or more Abre stents.
Overall Number of Participants Analyzed 200
Mean (Standard Deviation)
Unit of Measure: score on a scale
Change from Baseline to 6 Months Number Analyzed 190 participants
-4.0  (3.7)
Change from Baseline to 12 Months Number Analyzed 191 participants
-4.6  (4.3)
30.Secondary Outcome
Title Change in Venous Clinical Severity Score (VCSS) at 24 Months Compared to Baseline
Hide Description VCSS scores range from 0=no disease to 30=severe disease. Change in VCSS score was calculated as the Baseline score minus the Follow-up score (24 months). A negative change is associated with improved outcome.
Time Frame 24 Month
Outcome Measure Data Not Reported
31.Secondary Outcome
Title Change in Venous Clinical Severity Score (VCSS) at 36 Months Compared to Baseline
Hide Description VCSS scores range from 0=no disease to 30=severe disease. Change in VCSS score was calculated as the Baseline score minus the Follow-up score (36 months). A negative change is associated with improved outcome.
Time Frame 36 Month
Outcome Measure Data Not Reported
32.Secondary Outcome
Title Major Bleeding Complication at 30 Days, 6-, 12 Months
Hide Description A blood loss leading to transfusion of whole blood or red cells provided hemoglobin drop of 3 g/dL (1.86 mmol/L) or more is related to bleeding occurring during the index procedure through 12 months post-index procedure.
Time Frame 30 days, 6 months, and 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects with an event or a minimum number of follow-up days per time point.
Arm/Group Title ABRE
Hide Arm/Group Description:
Subjects implanted with one or more Abre stents.
Overall Number of Participants Analyzed 200
Measure Type: Count of Participants
Unit of Measure: Participants
30 Days Number Analyzed 200 participants
0
   0.0%
6 Months Number Analyzed 199 participants
0
   0.0%
12 Months Number Analyzed 195 participants
0
   0.0%
33.Secondary Outcome
Title Major Bleeding Complication at 24 Months
Hide Description A blood loss leading to transfusion of whole blood or red cells provided hemoglobin drop of 3 g/dL (1.86 mmol/L) or more is related to bleeding occurring during the index procedure through 24 months post-index procedure.
Time Frame 24 Month
Outcome Measure Data Not Reported
34.Secondary Outcome
Title Major Bleeding Complication at 36 Months
Hide Description A blood loss leading to transfusion of whole blood or red cells provided hemoglobin drop of 3 g/dL (1.86 mmol/L) or more is related to bleeding occurring during the index procedure through 36 months post-index procedure.
Time Frame 36 Month
Outcome Measure Data Not Reported
35.Secondary Outcome
Title Subject Re-hospitalization Through 12 Months
Hide Description Number of subjects that were re-hospitalized due to their target lesion within 180 days from the Index Procedure and number of subjects that were re-hospitalized due to their target lesion from 181 to 360 days from the Index Procedure.
Time Frame 6 and 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects with an event or a minimum number of follow-up days per time point.
Arm/Group Title ABRE
Hide Arm/Group Description:
Subjects implanted with one or more Abre stents.
Overall Number of Participants Analyzed 200
Measure Type: Count of Participants
Unit of Measure: Participants
0-180 days Number Analyzed 200 participants
11
   5.5%
181-360 Days Number Analyzed 199 participants
5
   2.5%
36.Secondary Outcome
Title Subject Re-hospitalization Through 24 Months
Hide Description [Not Specified]
Time Frame 24 Month
Outcome Measure Data Not Reported
37.Secondary Outcome
Title Subject Re-hospitalization Through 36 Months
Hide Description [Not Specified]
Time Frame 36 Month
Outcome Measure Data Not Reported
Time Frame Through 360 Days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title ABRE
Hide Arm/Group Description Subjects implanted with one or more Abre stents.
All-Cause Mortality
ABRE
Affected / at Risk (%)
Total   2/200 (1.00%)    
Hide Serious Adverse Events
ABRE
Affected / at Risk (%) # Events
Total   59/200 (29.50%)    
Blood and lymphatic system disorders   
ANAEMIA  1  2/200 (1.00%)  2
Cardiac disorders   
ACUTE LEFT VENTRICULAR FAILURE  1  1/200 (0.50%)  1
ACUTE MYOCARDIAL INFARCTION  1  1/200 (0.50%)  1
ATRIAL FIBRILLATION  1  4/200 (2.00%)  4
CARDIAC FAILURE CONGESTIVE  1  1/200 (0.50%)  1
SUPRAVENTRICULAR TACHYCARDIA  1  1/200 (0.50%)  1
Gastrointestinal disorders   
ABDOMINAL HERNIA  1  2/200 (1.00%)  2
ABDOMINAL WALL HAEMATOMA  1  1/200 (0.50%)  1
ANAL FISSURE  1  1/200 (0.50%)  1
HAEMORRHOIDS  1  1/200 (0.50%)  1
RETROPERITONEAL HAEMATOMA  1  1/200 (0.50%)  1
SMALL INTESTINAL OBSTRUCTION  1  1/200 (0.50%)  1
General disorders   
FATIGUE  1  1/200 (0.50%)  1
MULTIPLE ORGAN DYSFUNCTION SYNDROME  1  1/200 (0.50%)  1
PERIPHERAL SWELLING  1  1/200 (0.50%)  1
VASCULAR STENT STENOSIS  1  8/200 (4.00%)  10
VASCULAR STENT THROMBOSIS  1  18/200 (9.00%)  21
Infections and infestations   
INTERVERTEBRAL DISCITIS  1  1/200 (0.50%)  1
PNEUMONIA  1  3/200 (1.50%)  3
PYELONEPHRITIS  1  1/200 (0.50%)  1
SEPTIC SHOCK  1  1/200 (0.50%)  1
Injury, poisoning and procedural complications   
MENISCUS INJURY  1  2/200 (1.00%)  2
SPINAL COMPRESSION FRACTURE  1  1/200 (0.50%)  1
TENDON RUPTURE  1  1/200 (0.50%)  1
VASCULAR ACCESS SITE HAEMATOMA  1  2/200 (1.00%)  2
Investigations   
HAEMOGLOBIN DECREASED  1  1/200 (0.50%)  1
Musculoskeletal and connective tissue disorders   
ARTHRALGIA  1  1/200 (0.50%)  1
BACK PAIN  1  2/200 (1.00%)  2
INTERVERTEBRAL DISC PROTRUSION  1  1/200 (0.50%)  1
OSTEOARTHRITIS  1  3/200 (1.50%)  3
Nervous system disorders   
CEREBROVASCULAR ACCIDENT  1  1/200 (0.50%)  1
INTRACRANIAL ANEURYSM  1  1/200 (0.50%)  1
MIGRAINE  1  1/200 (0.50%)  1
NERVE COMPRESSION  1  1/200 (0.50%)  1
Renal and urinary disorders   
ACUTE KIDNEY INJURY  1  2/200 (1.00%)  2
HAEMATURIA  1  1/200 (0.50%)  1
Respiratory, thoracic and mediastinal disorders   
BRONCHIECTASIS  1  1/200 (0.50%)  1
DYSPNOEA EXERTIONAL  1  2/200 (1.00%)  2
EPISTAXIS  1  1/200 (0.50%)  1
PLEURAL EFFUSION  1  2/200 (1.00%)  2
PULMONARY EMBOLISM  1  1/200 (0.50%)  1
RESPIRATORY FAILURE  1  1/200 (0.50%)  1
Skin and subcutaneous tissue disorders   
SKIN ULCER  1  2/200 (1.00%)  2
STASIS DERMATITIS  1  1/200 (0.50%)  1
Vascular disorders   
DEEP VEIN THROMBOSIS  1  4/200 (2.00%)  4
LYMPHOEDEMA  1  2/200 (1.00%)  2
PERIPHERAL ARTERY STENOSIS  1  1/200 (0.50%)  2
PERIPHERAL VENOUS DISEASE  1  1/200 (0.50%)  1
VARICOSE VEIN  1  3/200 (1.50%)  4
VENA CAVA THROMBOSIS  1  1/200 (0.50%)  1
VENOUS HAEMORRHAGE  1  1/200 (0.50%)  1
1
Term from vocabulary, MedDRA (22.0)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
ABRE
Affected / at Risk (%) # Events
Total   13/200 (6.50%)    
Musculoskeletal and connective tissue disorders   
PAIN IN EXTREMITY  1  13/200 (6.50%)  13
1
Term from vocabulary, MedDRA (22.0)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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
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Name/Title: Stephanie Brucato, Clinical Study Manager
Organization: Medtronic
Phone: 508-463-8195
EMail: stephanie.m.brucato@medtronic.com
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Responsible Party: Medtronic Endovascular
ClinicalTrials.gov Identifier: NCT03038438    
Other Study ID Numbers: APV-ABRE
First Submitted: January 28, 2017
First Posted: January 31, 2017
Results First Submitted: January 4, 2021
Results First Posted: March 8, 2021
Last Update Posted: March 8, 2021