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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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General
Study Status Progress Adequate
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 The ABRE Continued Follow-Up Study is a prospective, multi-center follow-up of the ABRE pivotal study (G160163) that treated 200 subjects from 24 investigational sites. This study should be conducted per protocol APV – ABRE, Version 1.4 (dated September 24, 2018).
Study Population Description It will evaluate the long-term safety and effectiveness of the Abre venous self-expanding stent system. All 194 remaining subjects (6 subjects have discontinued the study), active at the end of the 12- month evaluation, will continue to be followed annually through 36 months.
Sample Size All 194 remaining subjects
Data Collection The primary endpoint to be assessed is freedom from target lesion revascularization (TLR) at 36 months, as defined by the protocol.

Secondary endpoints:

Overall rate and incidence of type of major adverse events from Day 0 through completion of Study follow-up at Month 36.

Primary stent patency rate: determined at Month 24 and Month 36 per protocol definition of primary stent patency.

Freedom from target lesion revascularization (TLR) at Month 24 and Month 36, as defined by the protocol.

Delayed Stent Migration at Month 24 and Month 36, as defined by the protocol.

Major bleeding complication at Month 24 and Month 36, as defined by the protocol.

Medical resource utilization through 36 months, as defined by the protocol.

Comparison of VCSS Scores measured at Baseline, Month 12, Month 24 and Month 36.

Comparison of VEINES-QOL/Sym Scores measured at Baseline, Month 12, Month 24 and Month 36.

Comparison of EQ-5D Quality of life Scores measured at Baseline, Month 12, Month 24 and Month 36. Comparison of Villalta Scores measured at Baseline, Month 12, Month 24 and Month 36.

Freedom from stent fracture, determined by core lab examination of X-rays at 24 and 36 Months.



Follow-up Visits and Length of Follow-up 36 months


ABRE Continued Follow-up Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 04/21/2021 04/21/2021 On Time
one year report 10/21/2021    
18 month report 04/21/2022    
two year report 10/21/2022    


Contact Us

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

Additional Resources

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