At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 293 enrolled
Drug / intervention
GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
GORE VIABAHN® Endoprosthesis Versus Percutaneous Transluminal Angioplasty (PTA) to Revise Arteriovenous Grafts at the Venous Anastomosis in Hemodialysis Patients
In Brief
A Phase 3 clinical trial evaluating GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface and Percutaneous Transluminal Angioplasty for Renal Failure and Hemodialysis. Completed, enrolled 293 participants across 31 sites.
Detailed 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 venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRenal Failure, Hemodialysis
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedAug 2008
Enrollment StartSep 2008
Primary CompletionMay 2011
Study CompletionJun 2013
TodayJul 2026
First PostedAug 19, 2008
Enrollment StartSep 1, 2008
Primary CompletionMay 1, 2011
Study CompletionJun 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 17.9 years ago
Interventions
GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surfacedevice
Deployment of investigational stent graft at the venous anastomosis
Percutaneous Transluminal Angioplastyprocedure
Percutaneous Transluminal Angioplasty at the venous anastomosis