We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2011 by American Access Care.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01271881
First Posted: January 7, 2011
Last Update Posted: January 7, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
American Access Care
December 1, 2010
January 7, 2011
January 7, 2011
October 2010
October 2011   (Final data collection date for primary outcome measure)
Primary patency at 3, 6, and 12 months [ Time Frame: 1 year ]
Target lesion primary patency at 3, 6, and 12 months
Same as current
No Changes Posted
Secondary patency at 3, 6, and 12 months [ Time Frame: 1 year ]
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
Same as current
Not Provided
Not Provided
 
Placement of Covered Stents to Treat Hemodialysis Access Stenoses in the Cephalic Arch and Central Veins
Placement of Covered Stents to Treat Hemodialysis Access Stenoses in the Cephalic Arch and Central Veins

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Hemodialysis
  • Other: PTA alone without use of the GORE VIABAHN
    PTA alone with no stent used
  • Device: GORE VIABAHN® Endoprosthesis with Heparin Bioactive Surface
    Covered stent produced by GORE VIABAHN
    Other Name: Covered stent
  • Active Comparator: Percutaneous Transluminal Angioplasty (PTA) alone
    Intervention: Procedure: PTA alone without use of the GORE VIABAHN
    Intervention: Other: PTA alone without use of the GORE VIABAHN
  • Experimental: PTA with covered stent
    GORE VIABAHN® Endoprosthesis with Heparin Bioactive Surface
    Intervention: Device: GORE VIABAHN® Endoprosthesis with Heparin Bioactive Surface

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
140
Not Provided
October 2011   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01271881
GORE-01
Yes
Not Provided
Not Provided
Dr. Abigail Falk, American Acess Care
American Access Care
Not Provided
Principal Investigator: Abigail Falk, Dr. American Access Care Physician
Study Chair: Claudio Cantu, RPA American Access Care Center Operations Manager
American Access Care
January 2011

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