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

Phase 3

Completed

• Conditions: Renal Failure; Hemodialysis
• Interventions: Procedure: Percutaneous Transluminal Angioplasty; Device: GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface

• Registration Number: NCT00737672
• Lead Sponsor: W.L.Gore & Associates

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.

Study Timeline

• Study First Submitted: 2008-08-15
• Study First Submitted QC: 2008-08-18
• Study First Posted: 2008-08-19
• Study Start: 2008-09
• Primary Completion: 2011-05
• Disposition First Submitted: 2013-05-14
• Disposition First Submitted QC: 2013-05-14
• Disposition First Posted: 2013-05-22
• Study Completion: 2013-06
• Results First Submitted: 2014-02-06
• Status Verified: 2014-10
• Results First Submitted QC: 2014-10-14
• Last Update Submitted: 2014-10-14
• Results First Posted: 2014-10-21
• Last Update Posted: 2014-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 293

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PTA Treatment Group	Percutaneous Transluminal Angioplasty	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
VIABAHN Treatment Group	GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface	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

Primary Outcome Measures

Name	Time	Method
Target Lesion Primary Patency at 12 Months	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	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	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	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 Outcome Measures

Name	Time	Method
Assisted Primary Patency at 12 Months	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.
Access Secondary Patency at 6 Months	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.
Circuit Primary Patency [24 Months] Units Percentage of Subjects	24 months	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.
Access Secondary Patency [12 Months] Units Percentage of Subjects	12 months	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.
Access Secondary Patency [24 Months] Units Percentage of Subjects	24 months	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.
Procedural Success	Following Index Procedure	Participants were considered to have Procedural Success if they achieved both anatomic success and clinical success.
Assisted Primary Patency at 6 Months	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.
Assisted Primary Patency at 24 Months	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.
Circuit Primary Patency	6 months	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.
Circuit Primary Patency [12 Months] Units Percentage of Subjects	12months	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.
Clinical Success	Following Index Procedure	The resumption of normal dialysis for at least one session following study treatment (Index Procedure).
Anatomic Success	Index Procedure	Less than 30 percent residual stenosis following study treatment (Index Procedure).