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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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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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OSB Lead-New Enrollment Study


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General
Study Status Progress Adequate
Application Number P040037 S060/ PAS002
Date Current Protocol Accepted 04/03/2015
Study Name OSB Lead-New Enrollment Study
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Historical Control
Analysis Type Descriptive
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description Objectives: to evaluate post-market safety and effectiveness of the GORE Viabahn endoprosthesis for treatment of ISR of the SFA.



Study design: a prospective, non-randomized, multicenter, single-arm observational study involving a minimum of 108 newly enrolled subjects.

Study Population Description Subjects presenting with symptomatic peripheral artery disease (Rutherford Category 2-5) with occlusive lesion(s) within and adjacent to previously implanted non-covered stent(s) located in the SFA.
Sample Size A total of 108 subjects, comprising of a minimum of 81 subjects in the US and maximum of 27 OUS subjects will be enrolled from 15 US and 5 OUS sites. The study population will include a minimum of 20 subjects with ISR lesion length 230- 270mm.

The sample size of 108 subjects is expected to yield an evaluable sample size of 86 subjects at 1-year after 20% lost to follow-up.

Data Collection Primary Effectiveness Endpoint: Primary Patency at 12 months

Primary Safety Endpoint:

Device- and procedure-related SAEs within 30 days of the index procedure



Secondary Endpoint:

Acute Procedural Success

Secondary endpoint to be evaluated at 30 days, 12, 24 and

36 months include: Primary Patency

Primary Assisted Patency

Secondary Patency

Freedom from Target Lesion Revascularization (TLR) Freedom from Major Amputation

Change in Ankle-Brachial Index from pre-procedure Change in Rutherford Category from pre-procedure Adverse Event Report

Stent Fracture Assessment at 12, 24 and 36 months by the Core Lab

Follow-up Visits and Length of Follow-up 3 years

30 days, 1, 2 and 3 years



OSB Lead-New Enrollment Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 03/20/2015 04/07/2015 Overdue/Received
one year report 09/19/2015 09/15/2015 On Time
18 month report 03/19/2016 03/15/2016 On Time
two year report 09/18/2016 09/16/2016 On Time
three year report 09/18/2017 09/13/2017 On Time
four year report 09/18/2018    
five year report 09/18/2019    


Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD
20993-0002

Phone: (301) 796-6134
Fax: (301) 847-8140
julie.unger@fda.hhs.gov

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