|
General |
Study Status |
Completed |
Application Number / Requirement Number |
P200026 / PAS001 |
Date Original Protocol Accepted |
10/21/2020
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Date Current Protocol Accepted |
 
|
Study Name |
ABRE Continued Follow-up Study
|
Device Name |
Abre Venous Self-expanding Stent System
|
General Study Protocol Parameters |
Study Design |
Prospective Cohort Study
|
Data Source |
New Data Collection
|
Comparison Group |
No Control
|
Analysis Type |
Descriptive
|
Study Population |
Adult: >21
|
Detailed Study Protocol Parameters |
Study Objectives |
To evaluate the long-term safety and effectiveness of the ABRE Stent System for treatment of symptomatic iliofemoral venous outflow obstruction in patients with venous occlusive disease through 36 months.
A prospective, multi-center, follow-up of the ABRE pivotal study
|
Study Population |
Subjects between 18 and 80 years (inclusive) requiring treatment of a non-malignant venous obstruction within the common iliac, external iliac and/or common femoral vein enrolled in the ABRE Study.
Subjects were categorized as acute DVT (aDVT), post-thrombotic syndrome (PTS), or non-thrombotic iliac vein lesion (NIVL)).
|
Sample Size |
A total of 200 subjects were enrolled at 24 sites in the U.S. and Europe, 128 (64%) of subjects enrolled at US sites and 72 (36%) subjects at European sites.
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Key Study Endpoints |
Primary Endpoint Freedom from target lesion revascularization (TLR) at 36 months. Secondary Endpoints The following secondary endpoints will be evaluated annually through 36 months post implant: Primary patency Primary assisted patency Secondary patency Target Lesion Revascularization (TLR) Major Adverse Events (MAE) Delayed Stent Migration Stent Fracture Change in VEINES-QOL/Sym Score Change in VILLALTA Score Change in EQ5D Quality of life Score Change in VCSS Score Major bleeding complication Medical resource utilization
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Follow-up Visits and Length of Follow-up |
36 months
|
Interim or Final Data Summary |
Actual Number of Patients Enrolled |
200
|
Actual Number of Sites Enrolled |
24
|
Patient Follow-up Rate |
98.9%
|
Final Safety Findings |
Through 1080 days a total of 414 adverse events (non-SAEs) were reported in 144 subjects. Musculoskeletal and connective tissue disorders (23.5%), Vascular Disorders (19.0%), General disorders and administration site conditions (17.5%), and Infections and Infestations (17.0%) were the most reported non-SAE SOCs. Subjects with aDVT mostly reported general disorders and administration site conditions with 24.2%, while 27.4% of subject with PTS reported musculoskeletal and connective tissue disorders, and 25.0% of subjects with NIVL reported vascular disorders.
|
Final Effect Findings |
The 36-month primary patency rate was 80.6%. Among the subjects evaluable for primary patency, the freedom from occlusion rate at 36 months was 98.5%, the freedom from restenosis rate at 36 months was 90.4%, and the freedom from clinically driven TLR through 1110 days was 85.9%. The primary assisted patency rate at 36 months was 86.4%. The secondary patency rate at 36 months was 90.4%.
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Study Strengths & Weaknesses |
Study strength: good follow up rates were achieved. Weakness: The study was a single-arm study without a control arm.
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Recommendations for Labeling Changes |
Yes
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