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
  Purpose

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.


Condition Intervention Phase
Renal Failure
Hemodialysis
Device: GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface
Procedure: Percutaneous Transluminal Angioplasty
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: GORE VIABAHN® Endoprosthesis Versus Percutaneous Transluminal Angioplasty (PTA) to Revise Arteriovenous Grafts at the Venous Anastomosis in Hemodialysis Patients

Resource links provided by NLM:


Further study details as provided by W.L.Gore & Associates:

Primary Outcome Measures:
  • Target Lesion Primary Patency [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assisted Primary Patency [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Access Secondary Patency [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 295
Study Start Date: September 2008
Study Completion Date: June 2013
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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
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
Procedure: Percutaneous Transluminal Angioplasty
Percutaneous Transluminal Angioplasty at the venous anastomosis

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00737672

  Show 30 Study Locations
Sponsors and Collaborators
W.L.Gore & Associates
Investigators
Study Director: Tom Vesely, MD Vascular Access Center; Frontenac, MO
  More Information

No publications provided

Responsible Party: W.L.Gore & Associates
ClinicalTrials.gov Identifier: NCT00737672     History of Changes
Other Study ID Numbers: AVR 06-01, G070069
Study First Received: August 15, 2008
Last Updated: January 23, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by W.L.Gore & Associates:
Hemodialysis
Stent Graft
Venous Anastomosis
Arteriovenous Grafts

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on October 19, 2014