|
|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P160004 / PAS001 |
| Study Name |
Continued F/u Study
|
| Device Name |
GORE TIGRIS VASCULAR STENT
|
| Clinical Trial Number(s) |
NCT01576055
|
| General Study Protocol Parameters |
| Study Design |
Randomized Clinical Trial
|
| Data Source |
New Data Collection
|
| Comparison Group |
Concurrent Control
|
| Analysis Type |
Descriptive
|
| Study Population |
Adult: At least 22 yrs
|
| Detailed Study Protocol Parameters |
| Study Objectives |
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 |
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All 218 remaining subjects (56 subjects have completed or withdrawn from the study) of the 274 original study subjects enrolled in the PCE 09-02 study from 36 investigational sites.
|
| Key Study Endpoints |
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
|
