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

Study Overview
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Brief Summary
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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.

Detailed Description
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This is a randomized, prospective, unblinded study with 1:1 randomization. Both groups will undergo PTA of stenotic lesion and patients will be randomized such that 50% will receive a covered stent in addition to the PTA. Patients will be followed at 3, 6, and 12 months post-procedure. Follow-up will be conducted with either angiographic and/or transonic measurements.

Official Title
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Placement of Covered Stents to Treat Hemodialysis Access Stenosis in the Cephalic Arch and Central Veins

Conditions
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Renal Failure

Intervention / Treatment
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* Device: GORE VIABAHN® Endoprosthesis with Heparin Bioactive Surface
* Procedure: PTA alone without use of the GORE VIABAHN


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Hemodialysis patient with a mature forearm or upper arm access that was created > 2 months before enrollment in study. The patient is ≥ 18 years of age. The patient has a reasonable expectation of remaining on hemodialysis for 12 months. The patient or his/her legal guardian understands the study and is willing and able to comply with follow-up requirements. The patient or his/her legal guardian is willing to provide informed consent. The patient has lesions that meet the angiographic inclusion / exclusion criteria and induce clinical, hemodynamic or functional abnormality. Exclusion Criteria: The patient has a known or suspected systemic infection. The patient has a known or suspected infection of the hemodialysis access and / or bacteremia. The patient is currently taking maintenance immunosuppressant medication such as rapamycin, mycophenolate or mycophenolic acid, prednisone (>10 mg per day), cyclosporine, tacrolimus, or cyclophosphamide. The patient has known bleeding disorder (e.g., hemophilia or von Willebrand's disease). The patient has known sensitivity to heparin. The patient is scheduled for a live donor kidney transplant. The patient is enrolled in another investigational study or another access maintenance trial The patient has comorbid conditions that may limit their ability to comply with the follow-up requirements. Life expectancy is ≤ 24 months. The patient has an untreatable allergy to radiographic contrast material. The patient is pregnant. In the opinion of the operating physician, the patient's hemodialysis access circuit is unsuitable for endovascular treatment. The patient's access is planned to be abandoned within 1 year. The patient has indwelling catheters (dialysis, pacemakers, ports). The patient has a central vein stent that would lead to jailing of the internal jugular vein. The patient experiences angioplasty-induced venous rupture. The patient has a flow limiting dissection after angioplasty. The patient's hemodialysis access is thrombosed.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 'PTA without use of the GORE VIABAHN'<br>Subjects randomized to 'PTA alone without use of the GORE VIABAHN' will receive the standard of care treatment which is Percutaneous Transluminal Angioplasty without the use of the 'GORE VIABAHN® Endoprosthesis with Heparin Bioactive Surface' | Procedure: PTA alone without use of the GORE VIABAHN<br>* Subject will receive standard of care PTA alone at the brachiocephalic stenosis without deployment of the'GORE VIABAHN® Endoprosthesis with Heparin Bioactive Surface'<br>|
| Experimental: PTA with covered stent<br>Subjects randomized to PTA with covered stent will receive Percutaneous Transluminal Angioplasty followed by the delivery of a 'GORE VIABAHN® Endoprosthesis with Heparin Bioactive Surface' . | Device: GORE VIABAHN® Endoprosthesis with Heparin Bioactive Surface<br>* The 'GORE VIABAHN® Endoprosthesis with Heparin Bioactive Surface' will be deployed at the brachiocephalic stenosis.<br>* Other names: Covered stent;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target lesion primary patency at 3, 6, and 12 months |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hemodialysis, Fistula, Angiograph, Angiogram