GORE VIABAHN Endoprosthesis Versus Percutaneous Transluminal Angioplasty (PTA) to Revise AV Grafts in Hemodialysis

Study Overview
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Brief Summary
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The objective of the study is to establish efficacy and safety of the GORE VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface when used to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis.

Detailed Description
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The primary effectiveness hypothesis is to demonstrate that the GORE VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface will extend the period of target lesion primary patency as compared to PTA. The primary safety hypothesis is to demonstrate that the proportion of subjects remaining free from major device, procedure, and treatment site-related adverse events through 30 days post-procedure in the GORE® VIABAHN® Device group is not inferior to that of the PTA group.

Official Title
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GORE VIABAHN® Endoprosthesis Versus Percutaneous Transluminal Angioplasty (PTA) to Revise Arteriovenous Grafts at the Venous Anastomosis in Hemodialysis Patients

Conditions
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Renal Failure, Hemodialysis

Intervention / Treatment
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* Device: GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface
* Procedure: Percutaneous Transluminal Angioplasty


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Hemodialysis patient with a dysfunctional or thrombosed forearm or upper arm prosthetic vascular access graft. The target lesion starts less than or equal to 30 mm from the venous anastomosis. The target lesion has > 50% stenosis as measured per protocol. The patient has a maximum of one secondary stenosis. Exclusion Criteria: The age of the hemodialysis access graft is less than or equal to 30 days old from the date of the study procedure. The patient has undergone an intervention (surgical or percutaneous) of the vascular access circuit less than or equal to 30 days from the date of the study procedure. The secondary lesion is an occlusion.

Ages Eligible for Study
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Minimum Age: 18 Years

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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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VIABAHN Treatment Group<br>Use of GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Comparator Arm | Device: GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface<br>* Deployment of investigational stent graft at the venous anastomosis<br>|
| Active Comparator: PTA Treatment Group<br>Percutaneous Transluminal Angioplasty (PTA) in arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Experimental Arm | Procedure: Percutaneous Transluminal Angioplasty<br>* Percutaneous Transluminal Angioplasty at the venous anastomosis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target Lesion Primary Patency at 6 Months | Kaplan-Meier estimate of the time interval of uninterrupted patency from initial study treatment to the next access thrombosis or intervention performed on the target lesion. Six-month estimate of target lesion primary patency derived from Kaplan-Meier curve. | 6 months | 
| Target Lesion Primary Patency at 12 Months | Kaplan-Meier estimate of the time interval of uninterrupted patency from initial study treatment to the next access thrombosis or intervention performed on the target lesion. Twelve-month estimate of target lesion primary patency derived from Kaplan-Meier curve. | 12 Months | 
| Target Lesion Primary Patency at 24 Months | Kaplan-Meier estimate of the time interval of uninterrupted patency from initial study treatment to the next access thrombosis or intervention performed on the target lesion. P-Value calculated from 24-month data cohort after study completion. | 24 Months | 
| Freedom From Major Device, Procedure and Treatment Site-related Adverse Adverse Events Through 30 Days Post-procedure | The primary safety endpoint is freedom from major device, procedure and treatment site-related adverse events through 30 days. | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assisted Primary Patency at 6 Months | Kaplan-Meier estimate of the time interval from initial study treatment to occlusion (thrombosis) of the vascular access circuit. Six-month estimate of assisted primary patency derived from Kaplan-Meier curve. | 6 months | 
| Assisted Primary Patency at 12 Months | Kaplan-Meier estimate of the time interval from initial study treatment to occlusion (thrombosis) of the vascular access circuit. Twelve-month estimate of assisted primary patency derived from Kaplan-Meier curve. | 12 months | 
| Assisted Primary Patency at 24 Months | Kaplan-Meier estimate of the time interval from initial study treatment to occlusion (thrombosis) of the vascular access circuit. Twenty-four-month estimate of assisted primary patency derived from Kaplan-Meier curve. | 24 months | 
| Access Secondary Patency at 6 Months | Kaplan-Meier estimate of the time interval from initial study treatment to abandonment of the vascular access circuit. Six-month estimate of secondary access patency derived from Kaplan-Meier curve. | 6 months | 
| Access Secondary Patency [12 Months] Units Percentage of Subjects | Kaplan-Meier estimate of the time interval from initial study treatment to abandonment of the vascular access circuit. Twelve-month estimate of secondary access secondary patency derived from Kaplan-Meier curve. | 12 months | 
| Access Secondary Patency [24 Months] Units Percentage of Subjects | Kaplan-Meier estimate of the time interval from initial study treatment to abandonment of the vascular access circuit. 24-month estimate of secondary access secondary patency derived from Kaplan-Meier curve. | 24 months | 
| Circuit Primary Patency | Kaplan-Meier estimate of the time interval from initial study treatment to the next access thrombosis or intervention performed within the vascular access circuit. P-Value calculated from 24-month data cohort. Six-month estimate of circuit primary patency derived from Kaplan-Meier curve. | 6 months | 
| Circuit Primary Patency [12 Months] Units Percentage of Subjects | Kaplan-Meier estimate of the time interval from initial study treatment to abandonment of the vascular access circuit. Twelve-month estimate of secondary access secondary patency derived from Kaplan-Meier curve. | 12months | 
| Circuit Primary Patency [24 Months] Units Percentage of Subjects | Kaplan-Meier estimate of the time interval from initial study treatment to abandonment of the vascular access circuit. Twelve-month estimate of secondary access secondary patency derived from Kaplan-Meier curve. | 24 months | 
| Clinical Success | The resumption of normal dialysis for at least one session following study treatment (Index Procedure). | Following Index Procedure | 
| Anatomic Success | Less than 30 percent residual stenosis following study treatment (Index Procedure). | Index Procedure | 
| Procedural Success | Participants were considered to have Procedural Success if they achieved both anatomic success and clinical success. | Following Index Procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hemodialysis, Stent Graft, Venous Anastomosis, Arteriovenous Grafts