N/A
N=124
GORE® VIABAHN® Endoprosthesis Post-Marketing Surveillance Study
Vascular Stent-Graft Stenosis
Bottom Line
View on ClinicalTrials.gov: NCT04429243 ↗Enrolled (actual)
124
Serious AEs
44.4%
Results posted
Nov 2024
Primary outcome: Primary: Number of Subjects With Loss of Primary Patency of Target Lesion — 81 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- GORE® VIABAHN® Stent Graft (Device)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- W.L.Gore & Associates
- Primary completion
- Oct 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Loss of Primary Patency of Target Lesion |
81 | — |
| PRIMARY Number of Subjects With Loss of Secondary Patency of Target Lesion |
17 | — |
| PRIMARY Number of Subjects With Loss of Primary Patency of Vascular Access Circuit |
98 | — |
| PRIMARY Number of Subjects With Loss of Secondary Patency of Vascular Access Circuit |
18 | — |
| PRIMARY Mean Cumulative Number of Re-treatment Per Target Lesion |
2.052 | — |
| PRIMARY Number of Subjects Achieving Technical Success |
110 | — |
| PRIMARY Number of Subjects Achieving Clinical Success |
72 | — |
| PRIMARY Number of Subjects Experiencing Device and Procedure-related Adverse Events |
4 | — |
| PRIMARY Number of Subjects Experiencing Device Defects |
— | — |
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.
Eligibility Criteria
Inclusion Criteria
- Participants who developed stenosis or occlusion at the venous anastomosis of synthetic arteriovenous access graft
- Participants who was used to repair vascular access circuits for purposes other than treatment of stenosis or occlusion at the venous anastomosis of synthetic arteriovenous access graft
Data sourced from ClinicalTrials.gov (NCT04429243). 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.