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Placement of Covered Stents to Treat Hemodialysis Access Stenoses in the Cephalic Arch and Central Veins

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by American Access Care.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
American Access Care
ClinicalTrials.gov Identifier:
NCT01271881
First received: December 1, 2010
Last updated: January 6, 2011
Last verified: January 2011
History of Changes
  Purpose

Balloon angioplasty is used to open up a narrowing that forms in hemodialysis fistula. Two areas of particular problems are the terminal portion of the cephalic vein near the shoulder and the central veins in the chest. Although angioplasty is standard of care the treated narrowed segments of vein mostly renarrow within 3 months requiring retreatment to keep your dialysis access functional. Recently there has been introduction of a new technology called a covered stent graft. Initial studies suggest that placing this device across the area of narrowing leads to dialysis access staying open longer and needing less angioplasty treatments.

This study is designed to compare angioplasty (standard of care) versus using a covered stent graft. The investigators will then look at the dialysis records and future fistulograms to see if there is decreased flow through the fistula at 3, 6 and 12 months after the initial procedure.


Condition Intervention
Hemodialysis
 Other: PTA alone without use of the GORE VIABAHN
Device: GORE VIABAHN® Endoprosthesis with Heparin Bioactive Surface

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Placement of Covered Stents to Treat Hemodialysis Access Stenoses in the Cephalic Arch and Central Veins

Resource links provided by NLM:

Drug Information available for: Heparin
U.S. FDA Resources

Further study details as provided by American Access Care:

Primary Outcome Measures:
  • Primary patency at 3, 6, and 12 months [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Target lesion primary patency at 3, 6, and 12 months


Secondary Outcome Measures:
  • Secondary patency at 3, 6, and 12 months [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Target lesion secondary patency at 3, 6, and 12 months, access circuit primary and secondary patency at 3, 6, and 12 months, anatomic, clinical, and procedural success. Adverse events through 1 month


Estimated Enrollment: 140
Study Start Date: October 2010
Estimated Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Percutaneous Transluminal Angioplasty (PTA) alone
Intervention: Procedure: PTA alone without use of the GORE VIABAHN
 Other: PTA alone without use of the GORE VIABAHN
PTA alone with no stent used
Experimental: PTA with covered stent
GORE VIABAHN® Endoprosthesis with Heparin Bioactive Surface
 Device: GORE VIABAHN® Endoprosthesis with Heparin Bioactive Surface
Covered stent produced by GORE VIABAHN
Other Name: Covered stent

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Hemodialysis patient with a mature forearm or upper arm access that was created > 2 months before enrollment in study.
  2. The patient is ≥ 18 years of age.
  3. The patient has a reasonable expectation of remaining on hemodialysis for 12 months.
  4. The patient or his/her legal guardian understands the study and is willing and able to comply with follow-up requirements.
  5. The patient or his/her legal guardian is willing to provide informed consent.
  6. The patient has lesions that meet the angiographic inclusion / exclusion criteria and induce clinical, hemodynamic or functional abnormality.

Exclusion Criteria:

  1. The patient has a known or suspected systemic infection.
  2. The patient has a known or suspected infection of the hemodialysis access and / or bacteremia.
  3. The patient is currently taking maintenance immunosuppressant medication such as rapamycin, mycophenolate or mycophenolic acid, prednisone (>10 mg per day), cyclosporine, tacrolimus, or cyclophosphamide.
  4. The patient has known bleeding disorder (e.g., hemophilia or von Willebrand's disease).
  5. The patient has known sensitivity to heparin.
  6. The patient is scheduled for a live donor kidney transplant.
  7. The patient is enrolled in another investigational study or another access maintenance trial
  8. The patient has comorbid conditions that may limit their ability to comply with the follow-up requirements
  9. Life expectancy is ≤ 24 months.
  10. The patient has an untreatable allergy to radiographic contrast material.
  11. The patient is pregnant.
  12. In the opinion of the operating physician, the patient's hemodialysis access circuit is unsuitable for endovascular treatment.
  13. The patient's access is planned to be abandoned within 1 year.
  14. The patient has indwelling catheters (dialysis, pacemakers, ports).
  15. The patient has a central vein stent that would lead to jailing of the internal jugular vein.
  16. The patient experiences angioplasty-induced venous rupture.
  17. The patient has a flow limiting dissection after angioplasty.
  18. The patient's hemodialysis access is thrombosed.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01271881

Contacts
Contact: Abigail Falk, Dr. 914-683-9731 abigailfalk123@pol.net
Contact: Claudio Cantu, RPA 914-683-9729 CCantu@aac-llc.com

Locations
United States, New York
American Access Care of Bronx Recruiting
Bronx, New York, United States, 10461
Contact: Abigail Falk, Dr.     718-794-9729     abigailfalk123@pol.net    
Principal Investigator: Abigail Falk, Dr.            
American Access Care of Queens Recruiting
Flushing, New York, United States, 11366
Contact: Kiran Jotwani, MD     718-820-9729        
Principal Investigator: Kiran Jotwani, MD            
Access Care Physicians of New York Recruiting
White Plains, New York, United States, 10601
Contact: Claudio Cantu, RPA     914-683-9729     CCacntu@aac-llc.com    
Principal Investigator: Claudio Cantu, RPA            
Sponsors and Collaborators
American Access Care
Investigators
Principal Investigator: Abigail Falk, Dr. American Access Care Physician
Study Chair: Claudio Cantu, RPA American Access Care Center Operations Manager
  More Information

Additional Information:
Angioplasty  This link exits the ClinicalTrials.gov site
Dialysis  This link exits the ClinicalTrials.gov site
Fistulas  This link exits the ClinicalTrials.gov site
Kidney Failure  This link exits the ClinicalTrials.gov site
Heparin  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Dr. Abigail Falk, American Acess Care
ClinicalTrials.gov Identifier: NCT01271881     History of Changes
Other Study ID Numbers: GORE-01
Study First Received: December 1, 2010
Last Updated: January 6, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by American Access Care:
Hemodialysis
Fistula
Angiograph
Angiogram
Adult patients who are currently receiving hemodialysis treatment via an AV vascular graft or fistula located in the upper extremity

Additional relevant MeSH terms:
Heparin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
 Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 19, 2013