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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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New Enrollment Study


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General
Study Status Completed
Application Number P040037 S060/ PAS002
Date Current Protocol Accepted 04/03/2015
Study Name 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
Interim or Final Data Summary
Actual Number of Patients Enrolled 108
Actual Number of Sites Enrolled 23
Patient Follow-up Rate 30 day visit: 101 out of 108 (93.5%)
12-month visit: 78 out of 95 (82.1%)
2-year follow-up visit: 61 out of 73 (83.6%)
3- year follow-up visit: 53 out of 61 (86.9%)
Final Safety Findings SAE events were reported within 30 days: Three (2.8%; sepsis, retroperitoneal bleed, groin hematoma)
Free from SAE within 30 days: 105 (97.2%)
Final Effect Findings Primary patency at 12-months for the intent-to-treat subject cohort is 71.5% (Kaplan-Meier Estimates 95% Confidence Interval: 60.7%, 79.7%).
Patency:
30 days: 99.0%
12 months: 71.5%
24 months: 56.1%
36 months: 44.9 %
Study Strengths & Weaknesses The follow-up compliance and study deviations were within reasonable expectations.
Recommendations for Labeling Changes Additional information is available from these results that supplements information already contained in the publicly available SSED and labeling. Therefore, labeling changes are recommended.


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 09/24/2018 Overdue/Received
five year report 09/18/2019 09/16/2019 On Time
six year report 09/18/2020 09/15/2020 On Time
final report 10/29/2021 10/21/2021 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

Additional Resources

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