Gore REVISE (GORE VIABAHN) Endoprosthesis versus Percutaneous Transluminal Angioplasty (PTA) to Revise Arteriovenous Grafts at the Venous Anastomosis in Hemodialysis Patients)
Primary Investigator:
Rodney Raabe, MD
Description:
The Gore REVISE study is a randomized study. It has been designed to establish the effectiveness and safety of the GORE VIABAHN® Endoprosthesis (stent) with PROPATEN Bioactive Surface in prosthetic hemodialysis grafts. This specialized graft will be used to treat narrowing at the venous end of the graft in order to maintain or re-establish the vascular access for hemodialysis. The goal of the study is to track the natural course of the vascular access as the Subject undergoes regular hemodialysis at their respective dialysis center. Participants will be followed at 1, 3, 6, 12, 18, and 24 - months post-procedure to assess the safety and effectiveness of the treatment.
Eligibility:
- Hemodialysis patient with a dysfunctional or thrombosed forearm or upper arm prosthetic vascular access graft.
- The patient is less than 18 years of age.
- The patient has a reasonable expectation of remaining on hemodialysis for 24 months.
- Other eligibility criteria may apply. Please contact study coordinator
Exclusions:
- The age of the hemodialysis access graft is 30 days or less from the date of the study procedure.
- The patient has undergone an intervention (surgical or percutaneous) of the vascular access circuit 30 days or less from the date of the study procedure.
- The patient has a native arteriovenous fistula currently used for hemodialysis.
- The patient has an existing stent or stent graft anywhere within the vascular access circuit.
- The patient has an existing hemodialysis graft that has not been cannulated for dialysis.
- The patient's hemodialysis graft is located in the thigh.
- The patient has a compound or hybrid vascular access (i.e. graft-fistula hybrid).
- The patient has a compound or hybrid vascular access (i.e. graft-fistula hybrid).
- Other exclusion criteria may apply. Please contact study coordinator.
Study Timeline:
Currently Enrolling
Study Sponsor:
W. L. Gore & Associates, Inc., Flagstaff, AZ