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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 Completed
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Sample Size All 218 remaining subjects (56 subjects have completed or withdrawn from the study) of the 274 original study subjects enrolled in the PCE 09-02 study from 36 investigational sites.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
Interim or Final Data Summary
Actual Number of Patients Enrolled 274
Actual Number of Sites Enrolled 36
Patient Follow-up Rate All follow-up visits for enrolled subjects through 36 months are complete with a total of 171 (87.7%) subjects who participated in the last 36 month visit on 30 Jun 2017. Two (2) additional subjects who were unable to physically attend the 36 month visit were able to call the site with completed questionnaires.
Final Safety Findings Estimates of freedom from MAE (survival probability) for the GORE® TIGRIS® device (56.3%) are similar to the Bard® LifeStent® (59.7%) through the end of study at 36 months.
Final Effect Findings The primary endpoint in this study is primary patency at 36 months after implantation, defined as uninterrupted patency without target lesion revascularization (TLR), including the proximal and distal margins, and no restenosis as documented by a peak systolic velocity ratio (PSVR) =2.5 by Color Doppler Ultrasound (CDUS). There is a similar primary patency rate at 36 months when comparing nominal values (46.0% Lifestent vs. 53.5% Tigris). The nominal difference between the groups with regard to TLR was smaller (63.8% Lifestent vs 65.7% Tigris) than the difference patency rates.

Study Strengths & Weaknesses The follow-up compliance and study deviations were within reasonable expectations.
Recommendations for Labeling Changes No additional information is available from these results that contradicts the information already contained in the publicly available SSED and labeling. Therefore, no labeling changes are recommended

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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