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

Recruiting in Palo Alto (17 mi)

+28 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: W.L.Gore & Associates

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

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.

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Treatment Details

Interventions

GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface (Endoprosthesis)
Percutaneous Transluminal Angioplasty (Procedure)

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: VIABAHN Treatment GroupExperimental Treatment1 Intervention

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

Group II: PTA Treatment GroupActive Control1 Intervention

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