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

W.L. Gore & Associates

Status and phase: Completed; Phase 3

Conditions: Hemodialysis; Renal Failure

Treatments: Device: GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface; Procedure: Percutaneous Transluminal Angioplasty

Study type: Interventional

Funder types: Industry

Identifiers

NCT00737672

AVR 06-01

G070069 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 293 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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293 participants in 2 patient groups

VIABAHN Treatment Group

Experimental group

Description:

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

Treatment:

Device: GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface

PTA Treatment Group

Active Comparator group

Description:

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

Treatment:

Procedure: Percutaneous Transluminal Angioplasty