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|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P040037 S060/ PAS002 |
| Date Original Protocol Accepted |
04/03/2015
|
| Date Current Protocol Accepted |
04/03/2015
|
| Study Name |
New Enrollment Study
|
| Device Name |
GORE VIABAHN ENDOPROSTHESIS AND GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE
|
| 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 Objectives |
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 |
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.
|
| Key Study Endpoints |
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.
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