N/A Completed N=124

GORE® VIABAHN® Endoprosthesis Post-Marketing Surveillance Study

Vascular Stent-Graft Stenosis

Source: ClinicalTrials.gov NCT04429243 ↗

Enrolled (actual)

124

Serious AEs

44.4%

Results posted

Nov 2024

Primary outcomePrimary: Number of Subjects With Loss of Primary Patency of Target Lesion — 81 Participants

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.

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	—	—

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

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.