Post Approval Study Investigating Lutonix Drug Coated Balloon for Treatment of Dysfunctional Arteriovenous Fistulae

Inclusion Criteria:

1. Male or non-pregnant, non-breastfeeding female ≥18 years of age

2. Subject is willing to provide informed consent, and is willing to comply with theprotocol-required follow up visits

3. Target lesion must be a mature arteriovenous fistula located in the arm presentingwith any clinical, physiological or hemodynamic abnormalities warrantingangiographic imaging as defined in the K/DOQI guidelines

4. Subject has a target lesion that can be treated with available LUTONIX DCB accordingto the Instructions For Use (IFU)

5. Venous stenosis of an AV fistula in which the target lesion is located from theanastomosis to the axillosubclavian junction, as defined by insertion of thecephalic vein

6. Successful pre-dilation of the target lesion with an uncoated percutaneoustransluminal angioplasty (PTA) balloon defined as:

7. No clinically significant dissection;

8. No extravasation requiring treatment;

9. Residual stenosis ≤30% by angiographic measurement;

10. Ability to completely efface the waist using the pre-dilation balloon.

Exclusion Criteria:

1. Subject is currently participating in an investigational drug, biologic, or devicestudy, or previous enrollment in this study

2. Subject has a non-controllable allergy to contrast

3. Subject has another medical condition that, in the opinion of the Investigator, mayconfound the data interpretation or is associated with a life expectancyinsufficient to allow for completion of subject study procedure and follow up

4. Target lesion is located central to the axillosubclavian junction

5. A thrombosed access or an access with a thrombosis treated ≤7 days before to theindex procedure

6. Prior surgical interventions of the access site ≤30 days before the index procedure

7. Target lesion is located within a bare metal or covered stent