|
General |
Study Status |
Completed |
Application Number / Requirement Number |
P040037 S050/ PAS001 |
Date Original Protocol Accepted |
10/18/2013
|
Date Current Protocol Accepted |
10/18/2013
|
Study Name |
Extended F/u 25cm Viabahn Endoprosthesis
|
Device Name |
GORE VIABAHN ENDOPROSTHESIS, GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE
|
General Study Protocol Parameters |
Study Design |
Prospective Cohort Study
|
Data Source |
New Data Collection
|
Comparison Group |
No Control
|
Analysis Type |
Descriptive
|
Interim or Final Data Summary |
Actual Number of Patients Enrolled |
71 (58 subjects available at 1 year).
|
Actual Number of Sites Enrolled |
6
|
Patient Follow-up Rate |
at 3 years (51 eligible subjects) – 90.2% (46/51)
|
Final Safety Findings |
Total number of device- or procedure-related adverse reported = 62 Most common organ class was general disorders and administration site conditions- 46 events Proportion of subjects with device- or procedure-related adverse events, overall - 50.7% (36/71)
Total number of device- or procedure-related serious adverse events reported = 40 Most common organ class was general disorders and administration site conditions- 31 events Proportion of subjects with device- or procedure-related serious adverse events, overall – 35.2% (25/71)
|
Final Effect Findings |
Primary Endpoint
The primary patency rate at 36 months by Kaplan Meier (KM) estimate was 40.6% Secondary Endpoints (by Kaplan Meier Analysis) Primary Assisted Patency rate at 24 and 36 months was 65.3% and 53.0% respectively
Secondary patency rate at 24 and 36 months was 96.9% at each timepoint
Freedom from target lesion revascularizations at 24 and 36 months was 65.1% and 55.5% respectively
Freedom from the composite of death, target vessel revascularization and amputation at 24 and 36 months was 56.5% and 44.5% respectively
The clinical Success rate at 24 and 36 months was 76.7% and 58.5% respectively. There were no reports of device fracture on X-ray
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Study Strengths & Weaknesses |
The study achieved an adequate follow-up rate of 90.2% at 3 years.
Weaknesses This was a single arm study without a comparator. Thus, the study result was not evaluated by a formal statistical test.
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Recommendations for Labeling Changes |
Labeling change is recommended to reflect the long term data from the post-approval study. The labeling change should include a new section on the label showing a summary of the post-approval study methods (including study objectives, design, population, number of enrolled sites/subjects, key endpoints, follow –up visits etc.), final results and study strengths and limitations of the PAS.
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