Study Comparing Lutonix AV Drug Coated Balloon vs Standard Balloon for Treatment of Dysfunctional AV Fistulae

Inclusion Criteria:

1. Age ≥21 years;

2. The subject is legally competent, has been informed of the nature, the scope and the
relevance of the study, voluntarily agrees to participation and the study's
provisions, and has duly signed the informed consent form (ICF);

3. Arteriovenous fistula located in the arm;

4. Native AV fistula was created ≥30 days prior to the index procedure and has undergone
one or more hemodialysis sessions;

5. Venous stenosis of an AV fistula with the target lesion located from the anastomosis
to the axillosubclavian junction and an abnormality attributable to the stenosis as
defined by K/DOQI guidelines.;

6. Successful pre-dilation of the target lesion with a percutaneous transluminal
angioplasty (PTA) balloon;

7. Intended target lesion or if a tandem lesion can be treated with ≤120 mm of DCBs in
length.

Exclusion Criteria:

1. Women who are pregnant, lactating, or planning on becoming pregnant during the study;

2. Hemodialysis access is located in the leg;

3. Subject has more than two lesions in the access circuit;

4. Subject has a secondary non-target lesion that cannot be successfully treated;

5. Target lesion is located central to the axillosubclavian junction;

6. The subject has a secondary lesion located in the central venous system (central to
the axillosubclavian junction);

7. A thrombosed access;

8. Surgical revision of the access site planned;

9. Recent prior surgical interventions of the access site;

10. Known contraindication (including allergic reaction) or sensitivity to iodinated
contrast media, that cannot be adequately managed with pre-and post-procedure
medication;

11. Known contraindication (including allergic reaction) or sensitivity to paclitaxel.

12. Subjects who are taking immunosuppressive therapy or are routinely taking

≥10mg of prednisone per day;

13. Subject has another medical condition, which, in the opinion of the Investigator, may
cause him/her to be noncompliant with the protocol or confound the data
interpretation;

14. Subject has a life expectancy <12 months;

15. Anticipated for a kidney transplant;

16. Anticipated conversion to peritoneal dialysis;

17. Subject has a stent located in the target or secondary non target lesion;

18. Subject has an infected AV access or systemic infection;

19. Currently participating in an investigational drug, biologic, or device study, or
previous enrollment in this study.