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

Completed · Phase 3

Conditions studied: Renal Failure, Hemodialysis

In brief

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.

Key facts

Study ID

NCT00737672

Run by

W.L.Gore & Associates

People needed

293

Starts

2008-09-01

Expected to finish

2013-06-01

Last updated by the study team

2014-10-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Study site — Birmingham, Alabama, United States
• Study site — Fresno, California, United States
• Study site — Inglewood, California, United States
• Study site — Oceanside, California, United States
• Study site — Riverside, California, United States
• Study site — San Diego, California, United States
• Study site — San Diego, California, United States
• Study site — San Francisco, California, United States
• Study site — New Haven, Connecticut, United States
• Study site — Jacksonville, Florida, United States
• Study site — Albany, Georgia, United States
• Study site — Chicago, Illinois, United States
• Study site — Des Moines, Iowa, United States
• Study site — Louisville, Kentucky, United States
• Study site — Baltimore, Maryland, United States
• Study site — New Brighton, Minnesota, United States
• Study site — Saint Paul, Minnesota, United States
• Study site — Cincinnati, Ohio, United States
• Study site — Cincinnati, Ohio, United States
• Study site — Dayton, Ohio, United States
• Study site — Portland, Oregon, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Charleston, South Carolina, United States
• Study site — Greenville, South Carolina, United States
• Study site — Beaumont, Texas, United States

Full record on ClinicalTrials.gov

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