Status:

COMPLETED

GORE® VIABAHN® Endoprosthesis Post-Marketing Surveillance Study

Lead Sponsor:

W.L.Gore & Associates

Conditions:

Vascular Stent-Graft Stenosis

Eligibility:

All Genders

Brief 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 steno...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    July 2 2020

    Trial Type :

    OBSERVATIONAL

    Allocation :

    ACTUAL

    End Date :

    October 6 2023

    Estimated Enrollment :

    124 Patients enrolled

    Trial Details

    Trial ID

    NCT04429243

    Start Date

    July 2 2020

    End Date

    October 6 2023

    Last Update

    November 29 2024

    Active Locations (17)

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    Page 1 of 5 (17 locations)

    1

    Kaikoukai Central Clinic

    Nagoya, Aichi-ken, Japan, 454-0933

    2

    Nagoya Vascular Access Clinic

    Nagoya, Aichi-ken, Japan, 464-0850

    3

    Matsuyama Red Cross Hospital

    Matsuyama, Ehime, Japan, 790-8524

    4

    Kansai Rosai Hospital

    Amagasaki, Hyōgo, Japan, 660-8511