GORE® VIABAHN® Endoprosthesis Post-Marketing Surveillance Study

Study Overview
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Brief Summary
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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.

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

Conditions
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Vascular Stent-Graft Stenosis

Intervention / Treatment
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* Device: GORE® VIABAHN® Stent Graft


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| GORE® VIABAHN® Stent Graft<br>Participants will be examined 1, 3, 6, 12 and 24 months following the GORE® VIABAHN® Stent Graft installation. | Device: GORE® VIABAHN® Stent Graft<br>* On Day 1, participants will receive the GORE® VIABAHN® Stent Graft.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Patency of Target Lesion | 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. | up to 2 years | 
| Secondary patency of target lesion | 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). | up to 2 years | 
| Primary Patency of Vascular Access Circuit | 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. | up to 2 years | 
| Secondary Patency of Vascular Access Circuit | 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. | up to 2 years | 
| Mean Cumulative Number of Re-treatment in Target Lesion | 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. | up to 2 years | 
| Number of Subjects Achieving Technical Success | Technical Success is defined as < 30% residual stenosis after initial treatment. | Day 1 | 
| Number of Subjects Achieving Clinical Success | Clinical Success is defined as the resumption of normal dialysis for at least one session after the initial treatment. | Day 1 to Month 1 follow up | 
| Number of Subjects Experiencing Adverse Events | 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. | Day 1 to Month 1 follow up | 
| Number of Subjects Experiencing Device Defects | 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. | Day 1 to Month 1 follow up |