Recruiting

Covered Stents

Sponsor:

American Access Care

Code:

NCT01271881

Conditions

Hemodialysis

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

PTA alone without use of the GORE VIABAHN

GORE VIABAHN® Endoprosthesis with Heparin Bioactive Surface

Study Details

Brief summary:

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.

Conditions

Hemodialysis

Study ID

NCT01271881

Start date

Oct, 2010

Status verified date

Jan, 2011

Primary completion date

Oct, 2011

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

140 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Percutaneous Transluminal Angioplasty (PTA) alone

Intervention: Procedure: PTA alone without use of the GORE VIABAHN

experimental: PTA with covered stent

GORE VIABAHN® Endoprosthesis with Heparin Bioactive Surface

Interventions

PTA alone without use of the GORE VIABAHN

PTA alone with no stent used

GORE VIABAHN® Endoprosthesis with Heparin Bioactive Surface

Covered stent produced by GORE VIABAHN

Primary outcome measure

  • Primary patency at 3, 6, and 12 months [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Locations

American Access Care of Bronx

Recruiting

Bronx, New York, United States, 10461

Contacts

Principal Investigator:

Abigail Falk, Dr.

American Access Care of Queens

Recruiting

Flushing, New York, United States, 11366

Contacts

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

Contacts

Principal Investigator:

Claudio Cantu, RPA

More Information

Sponsor

American Access Care

Last update posted

Jan 7, 2011

Last verified

Jan, 2011

Keywords

  • Hemodialysis
  • Fistula
  • Angiograph
  • Angiogram
  • Adult patients who are currently receiving hemodialysis treatment via an AV vascular graft or fistula located in the upper extremity

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by American Access Care on 2011-01-07.