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GORE® VIABAHN® Endoprosthesis Post-Marketing Surveillance Study

NCT04429243 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 124

Last updated 2024-11-29

Study results available
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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

  • Vascular Stent-Graft Stenosis

Interventions

DEVICE

GORE® VIABAHN® Stent Graft

On Day 1, participants will receive the GORE® VIABAHN® Stent Graft.

Sponsors & Collaborators

  • W.L.Gore & Associates

    lead INDUSTRY

Principal Investigators

  • Kei Kaneko · W. L. Gore & Associates G.K

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-02
Primary Completion
2023-10-06
Completion
2023-10-06
FDA Device
Yes

Countries

  • Japan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04429243 on ClinicalTrials.gov