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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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ODE Lead-Continued F/u Study

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Study Status Progress Adequate
Application Number P160004 / PAS001
Study Name ODE Lead-Continued F/u Study
General Study Protocol Parameters
Study Design Randomized Clinical Trial
Data Source New Data Collection
Comparison Group Concurrent Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description This study is a continued follow-up of the pre-market cohort (PCE 09-02). The PCE 09-02 study is a prospective, randomized, multi-center trial designed to study the long term safety and effectiveness of the GORE TIGRIS vascular stent when used in the treatment of atherosclerotic lesions of the superficial femoral and proximal popliteal arties.
Study Population Description Subjects with the Tigris Stent and the Lifestent Comparator device
Sample Size All 218 remaining subjects (56 subjects have completed or withdrawn from the study) of the 274 original study subjects enrolled in the PCE 09-02 study from 36 investigational sites.
Data Collection Primary Effectiveness Endpoint: Primary Patency at 36 months after implant

Secondary Endpoints:

At 2 and 3 years post-implant

Freedom from MAE (death, TVR, or index limb amputation)

Freedom from TVR

Freedom from TLR

Rutherford Improvement: Improvement in Rutherford Classification by at least 1 class

Ankle-Brachial Index (ABI) from pre-procedure

Quality of Life: Change in overall Quality of Life (EQ-5D) and disease-specific Quality of Life (Peripheral Artery Questionnaire [PAQ]) from Baseline

Primary patency at 24 months

Assisted primary patency

Secondary patency

Freedom from fracture

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

ODE Lead-Continued F/u Study Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
six month report 01/25/2017 01/25/2017 On Time
one year and Final report 10/31/2017 10/31/2017 On Time

Contact Us

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

Phone: (301) 796-6134
Fax: (301) 847-8140

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