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U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database

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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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ABRE Continued Follow-up Study

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Study Status Completed
Application Number P200026 / PAS001
Date Current Protocol Accepted  
Study Name ABRE Continued Follow-up Study
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 Design Description 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 Description 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.
Data Collection 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

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%.
Study Strengths & Weaknesses Study strength: good follow up rates were achieved. Weakness: The study was a single-arm study without a control arm.
Recommendations for Labeling Changes Yes

ABRE Continued Follow-up Study Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
six month report 04/21/2021 04/21/2021 On Time
1 year report 10/21/2021 10/15/2021 On Time
final report 04/28/2022 04/28/2022 On Time

Contact Us

Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

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