GORE® VIABAHN® Endoprosthesis Post-Marketing Surveillance Study (JPS 16-03)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Peripheral Arterial Disease
- Sponsor
- W.L.Gore & Associates
- Enrollment
- 321
- Locations
- 1
- Primary Endpoint
- Primary Assisted Patency
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
This study will confirm device efficacy and safety in the clinical setting after the launch of the GORE® VIABAHN® Endoprosthesis for the treatment of symptomatic peripheral arterial disease in the superficial femoral arteries.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Symptomatic peripheral arterial disease in superficial femoral artery lesions
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Primary Assisted Patency
Time Frame: 12 and 24 months
Primary assisted patency is defined as hemodynamic evidence of flow through a device that had not required a Target lesion revascularization to restore flow after total occlusion. Kaplan-Meier estimates created for each time point.
Freedom From Target Lesion Revascularization
Time Frame: 1, 12 and 24 months
Revascularization for restenosis or occlusion of the target lesion. Kaplan-Meier estimates created for each time point.
Number of Participants With One or More Device- or Procedure-related Serious Adverse Events and Deficiencies
Time Frame: Procedure day, 1, 12, 24, 36, 48 and 60 months
The number and proportion of the subjects for whom the occurrence of serious adverse events were reported.
Number of Participants With a Stent Fracture
Time Frame: Month 12, 24, 36, 48 and 60
The number and proportion of stent fracture as assessed by Core lab