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General |
Study Status |
Completed |
Application Number / Requirement Number |
P040037 S060/ PAS002 |
Date Original Protocol Accepted |
04/03/2015
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Date Current Protocol Accepted |
04/03/2015
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Study Name |
New Enrollment Study
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Device Name |
GORE VIABAHN ENDOPROSTHESIS AND GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE
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General Study Protocol Parameters |
Study Design |
Prospective Cohort Study
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Data Source |
New Data Collection
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Comparison Group |
Historical Control
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Analysis Type |
Descriptive
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Study Population |
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
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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.
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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.
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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.
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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
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Follow-up Visits and Length of Follow-up |
3 years 30 days, 1, 2 and 3 years
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Interim or Final Data Summary |
Actual Number of Patients Enrolled |
108
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Actual Number of Sites Enrolled |
23
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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%)
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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%)
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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 %
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Study Strengths & Weaknesses |
The follow-up compliance and study deviations were within reasonable expectations.
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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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