GORE VIABAHN® Endoprosthesis Versus Percutaneous Transluminal Angioplasty (PTA) to Revise Arteriovenous Grafts at the Venous Anastomosis in Hemodialysis Patients
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Renal Failure
- Sponsor
- W.L.Gore & Associates
- Enrollment
- 293
- Primary Endpoint
- Target Lesion Primary Patency at 12 Months
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
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
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.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Target Lesion Primary Patency at 12 Months
Time Frame: 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.
Target Lesion Primary Patency at 24 Months
Time Frame: 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.
Freedom From Major Device, Procedure and Treatment Site-related Adverse Adverse Events Through 30 Days Post-procedure
Time Frame: 30 days
The primary safety endpoint is freedom from major device, procedure and treatment site-related adverse events through 30 days.
Target Lesion Primary Patency at 6 Months
Time Frame: 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.
Secondary Outcomes
- Assisted Primary Patency at 12 Months(12 months)
- Access Secondary Patency at 6 Months(6 months)
- Circuit Primary Patency [24 Months] Units Percentage of Subjects(24 months)
- Access Secondary Patency [12 Months] Units Percentage of Subjects(12 months)
- Access Secondary Patency [24 Months] Units Percentage of Subjects(24 months)
- Procedural Success(Following Index Procedure)
- Assisted Primary Patency at 6 Months(6 months)
- Assisted Primary Patency at 24 Months(24 months)
- Circuit Primary Patency(6 months)
- Circuit Primary Patency [12 Months] Units Percentage of Subjects(12months)
- Clinical Success(Following Index Procedure)
- Anatomic Success(Index Procedure)