GORE® VIABAHN® Endoprosthesis Post-Marketing Surveillance Study (JPS 16-03)
Sponsor
W.L.Gore & Associates (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04706273
Collaborator
(none)
250
1
75.6
3.3
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational
Anticipated Enrollment
:
250 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
GORE® VIABAHN® Endoprosthesis Post-Marketing Surveillance Study (JPS 16-03)
Actual Study Start Date
:
Aug 25, 2016
Actual Primary Completion Date
:
Jul 11, 2019
Anticipated Study Completion Date
:
Dec 14, 2022
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| GORE® VIABAHN® Endoprosthesis Participants with symptomatic peripheral arterial disease in superficial femoral artery lesions. |
Device: GORE® VIABAHN® Endoprosthesis
On Day 1, Participants will receive the GORE® VIABAHN® Endoprosthesis
|
Outcome Measures
Primary Outcome Measures
- Primary Assisted Patency [Day 1 to Month 24]
Primary assisted patency is defined as hemodynamic evidence of flow through a device that had not required a TLR to restore flow after total occlusion.
- Freedom from Revascularization [Day 1 to Month 24]
Revascularization for restenosis or occlusion of the treatment lesion
Secondary Outcome Measures
- Number of Serious Adverse Events [Day 1 to Month 60]
- Rate of Stent Fractures [Day 1 to Month 60]
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- Symptomatic peripheral arterial disease in superficial femoral artery lesions
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Kansai Rousai | Amagasaki | Hyogo | Japan |
Sponsors and Collaborators
- W.L.Gore & Associates
Investigators
- Study Director: Kei Kaneko, W. L. Gore & Associates G.K
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
W.L.Gore & Associates
ClinicalTrials.gov Identifier:
NCT04706273
Other Study ID Numbers:
- JPS 16-03
First Posted:
Jan 12, 2021
Last Update Posted:
Dec 7, 2021
Last Verified:
Dec 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
Yes
Additional relevant MeSH terms: