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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
W.L.Gore & Associates
ClinicalTrials.gov Identifier:
NCT00737672
First received: August 15, 2008
Last updated: January 23, 2014
Last verified: January 2014

August 15, 2008
January 23, 2014
September 2008
May 2011   (final data collection date for primary outcome measure)
Target Lesion Primary Patency [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00737672 on ClinicalTrials.gov Archive Site
  • Assisted Primary Patency [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Access Secondary Patency [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
GORE VIABAHN Endoprosthesis Versus Percutaneous Transluminal Angioplasty (PTA) to Revise AV Grafts in Hemodialysis
GORE VIABAHN® Endoprosthesis Versus Percutaneous Transluminal Angioplasty (PTA) to Revise Arteriovenous Grafts at the Venous Anastomosis in Hemodialysis Patients

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Renal Failure
  • Hemodialysis
  • Device: GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface
    Deployment of investigational stent graft at the venous anastomosis
    Other Name: GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface
  • Procedure: Percutaneous Transluminal Angioplasty
    Percutaneous Transluminal Angioplasty at the venous anastomosis
  • Experimental: 1
    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
    Intervention: Device: GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface
  • Active Comparator: 2
    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
    Intervention: Procedure: Percutaneous Transluminal Angioplasty
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
295
June 2013
May 2011   (final data collection date for primary outcome measure)

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.
  • The patient has a maximum of one secondary stenosis.

Exclusion Criteria:

  • 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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00737672
AVR 06-01, G070069
Yes
W.L.Gore & Associates
W.L.Gore & Associates
Not Provided
Study Director: Tom Vesely, MD Vascular Access Center; Frontenac, MO
W.L.Gore & Associates
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP