N/A
N=321
GORE® VIABAHN® Endoprosthesis Post-Marketing Surveillance Study (JPS 16-03)
Peripheral Arterial Disease
Bottom Line
View on ClinicalTrials.gov: NCT04706273 ↗Enrolled (actual)
321
Serious AEs
58.6%
Results posted
Sep 2024
Primary outcome: Primary: Primary Assisted Patency — 0.920; 0.873 probability
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- GORE® VIABAHN® Endoprosthesis (Device)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- W.L.Gore & Associates
- Primary completion
- Jul 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Primary Assisted Patency |
0.920; 0.873 | — |
| PRIMARY Freedom From Target Lesion Revascularization |
0.997; 0.924; 0.844 | — |
| PRIMARY Number of Participants With One or More Device- or Procedure-related Serious Adverse Events and Deficiencies |
7; 11; 3; 9; 17; 20 | — |
| PRIMARY Number of Participants With a Stent Fracture |
0; 0; 0; 0; 0 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Symptomatic peripheral arterial disease in superficial femoral artery lesions
Data sourced from ClinicalTrials.gov (NCT04706273). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.