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

This is an interventional treatment trial for Hemodialysis focused on measuring Hemodialysis, Fistula, Angiograph, Angiogram, Adult patients who are currently receiving hemodialysis treatment via an AV vascular graft or fistula located in the upper extremity Read More

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.