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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
293
Deployment of investigational stent graft at the venous anastomosis
Percutaneous Transluminal Angioplasty at the venous anastomosis
Unnamed facility
Birmingham, Alabama, United States
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 30 days
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.
Time frame: 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.
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Unnamed facility
Fresno, California, United States
Unnamed facility
Inglewood, California, United States
Unnamed facility
Oceanside, California, United States
Unnamed facility
Riverside, California, United States
Unnamed facility
San Diego, California, United States
Unnamed facility
San Diego, California, United States
Unnamed facility
San Francisco, California, United States
Unnamed facility
New Haven, Connecticut, United States
Unnamed facility
Jacksonville, Florida, United States
...and 21 more locations
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 24 months
Clinical Success
The resumption of normal dialysis for at least one session following study treatment (Index Procedure).
Time frame: Following Index Procedure
Anatomic Success
Less than 30 percent residual stenosis following study treatment (Index Procedure).
Time frame: Index Procedure
Procedural Success
Participants were considered to have Procedural Success if they achieved both anatomic success and clinical success.
Time frame: Following Index Procedure