Status:
COMPLETED
GORE VIABAHN Endoprosthesis Versus Percutaneous Transluminal Angioplasty (PTA) to Revise AV Grafts in Hemodialysis
Lead Sponsor:
W.L.Gore & Associates
Conditions:
Renal Failure
Hemodialysis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 venou...
Detailed 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....
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
293 Patients enrolled
Trial Details
Trial ID
NCT00737672
Start Date
September 1 2008
End Date
June 1 2013
Last Update
October 21 2014
Active Locations (31)
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1
Birmingham, Alabama, United States, 35249
2
Fresno, California, United States, 93710
3
Inglewood, California, United States, 90301
4
Oceanside, California, United States, 92056