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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
W.L.Gore & Associates
ClinicalTrials.gov Identifier:
NCT00737672
First received: August 15, 2008
Last updated: April 22, 2013
Last verified: April 2013
History of Changes
  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:

MedlinePlus related topics: Angioplasty Dialysis
U.S. FDA Resources

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 ]

Estimated Enrollment: 280
Study Start Date: September 2008
Estimated 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
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: April 22, 2013
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 May 16, 2013