Trials / Completed
CompletedNCT04429243
GORE® VIABAHN® Endoprosthesis Post-Marketing Surveillance Study
GORE® VIABAHN® Endoprosthesis Post-Marketing Surveillance Study - Treatment of Patients With Stenosis or Occlusion at the Venous Anastomosis of Synthetic Arteriovenous (AV) Access Graft
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 124 (actual)
- Sponsor
- W.L.Gore & Associates · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
This study will confirm the efficacy and safety in the clinical setting after the launch of the GORE® VIABAHN® stent graft (hereafter referred to as "Viabahn") for the treatment of patients with stenosis or occlusion at the venous anastomosis of synthetic arteriovenous access graft.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | GORE® VIABAHN® Stent Graft | On Day 1, participants will receive the GORE® VIABAHN® Stent Graft. |
Timeline
- Start date
- 2020-07-02
- Primary completion
- 2023-10-06
- Completion
- 2023-10-06
- First posted
- 2020-06-12
- Last updated
- 2024-11-29
- Results posted
- 2024-11-29
Locations
17 sites across 1 country: Japan
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04429243. Inclusion in this directory is not an endorsement.