|
|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P040037 S060/ PAS001 |
| Date Original Protocol Accepted |
09/19/2014
|
| Date Current Protocol Accepted |
09/19/2014
|
| Study Name |
RELINE Extended F/U Study
|
| Device Name |
GORE VIABAHN ENDOPROSTHESIS AND GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE
|
| General Study Protocol Parameters |
| Study Design |
Randomized Clinical Trial
|
| Data Source |
New Data Collection
|
| Comparison Group |
Concurrent Control
|
| Analysis Type |
Descriptive
|
| Study Population |
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
100 (47 Viabhn and 53 POBA)
88 subjects (42 Viabahn and 46 POBA) were available at 1 year for the PAS
|
| Actual Number of Sites Enrolled |
7
|
| Patient Follow-up Rate |
90.9% (80/88) at 2-year follow-up visit (based on the number of subjects available at 1 year for the
PAS)
|
| Final Safety Findings |
A total of 178 Serious Adverse Events, 80 in the Viabahn treatment group and 98 in the POBA Control group were reported through 24 months.
|
| Final Effect Findings |
Primary Endpoint
Primary patency at 24 months by Kaplan-Meier (KM) estimate for the Viabahn group was
59.6% versus 10% for the POBA Control group (log rank test p-value: p <0.001)
Secondary Endpoints
Primary assisted patency at 24 months (KM estimate) was 74.8% for the Viabahn group versus 47.9%
for the and POBA Control group (log rank test p-value: p =0.008)
Secondary patency at 24 months (KM estimate) was 90.6% for the Viabahn group and 69.5% for the control group at 24 month follow-up (log rank test p-value: p =0.010).
Freedom from target lesion revascularization (KM estimate) for the Viabahn group was
68.1% versus 19.6% for the POBA control group (log rank test p-value: p<0.001).
Clinical success was achieved by 88.9% (32/36) of Viabahn subjects and 90.2% (37/41) of Control subjects at 24 months (Fisher¿s Exact test, P = 1.0)
|
| Study Strengths & Weaknesses |
The post-approval study subjects were randomized subjects who were followed through 2 years post stent implant. As such the limitations associated with observational studies are expected to be reduced in this two-arm randomized study. The primary and secondary endpoints for the Viabahn group were evaluated against POBA Control group by formal statistics.
Study Weaknesses
No issues of significance were identified.
|
| Recommendations for Labeling Changes |
Labeling change is recommended to reflect the 2-year long-term results 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.), results and study strengths and limitations.
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