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Completed

NCT Number: NCT04429243

GORE® VIABAHN® Endoprosthesis Post-Marketing Surveillance Study

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.

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Key information

Conditions

Vascular Stent-Graft Stenosis

Sex eligibility

All sexes

Study type

Observational

Primary location

Kaikoukai Central Clinic, Nagoya, Aichi-ken, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GORE® VIABAHN® Stent Graft

Device

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

Primary outcomes

  1. Number of Subjects With Loss of Primary Patency of Target Lesion

    Time frame: up to 2 years

    Primary patency of target lesion is defined as the period during the patency was maintained from initial treatment until occlusion of target lesion or re-treatment of target lesion.

  2. Number of Subjects With Loss of Secondary Patency of Target Lesion

    Time frame: up to 2 years

    Secondary patency of target lesion is defined as the period during the patency was maintained from initial treatment (including the period of patency after re-treatment).

  3. Number of Subjects With Loss of Primary Patency of Vascular Access Circuit

    Time frame: up to 2 years

    Primary patency of vascular access circuit is defined as the period during the patency was maintained from initial treatment until occlusion in vascular access or re-treatment in vascular access circuit.

  4. Number of Subjects With Loss of Secondary Patency of Vascular Access Circuit

    Time frame: up to 2 years

    Secondary patency of vascular access circuit is defined as the period during the patency was maintained from initial treatment until discontinuation of the use of vascular access circuit.

  5. Mean Cumulative Number of Re-treatment Per Target Lesion

    Time frame: at 24 months

    Mean cumulative number of re-treatment in target lesion is defined as the number of re-treatment performed for target lesion after the initial treatment.

  6. Number of Subjects Achieving Technical Success

    Time frame: Day 1

    Technical Success is defined as < 30% residual stenosis after initial treatment.

  7. Number of Subjects Achieving Clinical Success

    Time frame: Day 1 to Month 1 follow up

    Clinical Success is defined as the resumption of normal dialysis for at least one session after the initial treatment.

  8. Number of Subjects Experiencing Device and Procedure-related Adverse Events

    Time frame: Day 1 to Month 1 follow up

    An adverse event (AE) is defined as any unfavorable or unintended sign (including abnormal laboratory changes), symptom, or illness associated with the use of a medical device. Unless worsening of severity or increasing of incidence during the surveillance, the primary disease of the patient is not considered an adverse event.

  9. Number of Subjects Experiencing Device Defects

    Time frame: Day 1 to Month 1 follow up

    A device defect is defined as a defect such as damage, malfunction, etc. that are widely unfavorable. Regardless of whether they are due to design, marketing, distribution, or use.

Sponsors and collaborators

Lead sponsor

W.L.Gore & Associates

Industry

Registry information

Official study title

GORE® VIABAHN® Endoprosthesis Post-Marketing Surveillance Study - Treatment of Patients With Stenosis or Occlusion at the Venous Anastomosis of Synthetic Arteriovenous (AV) Access Graft

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Jun 12, 2020
Registry last updated
Nov 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.