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 the
protocol-required follow up visits

3. Target lesion must be a mature arteriovenous fistula located in the arm presenting
with any clinical, physiological, or hemodynamic abnormalities warranting angiographic
imaging as defined in the National Kidney Foundation Kidney Disease Outcomes Quality
Initiative (NKF KDOQI)™guidelines.

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

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

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

1. No clinically significant dissection;

2. No extravasation requiring treatment;

3. Residual stenosis ≤30% by angiographic measurement;

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

7. Total lesion length is ≤80mm, which may include tandem lesions that are ≤20mm apart

Exclusion Criteria:

1. Subject is currently participating in an investigational drug, biologic, or device
study, 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, may
confound the data interpretation or is associated with a life expectancy insufficient
to allow for completion of subject study procedure and follow up

4. Subject has more than one (1) lesion in the access circuit requiring treatment

5. Target lesion is located central to the axillosubclavian junction

6. A thrombosed access or an access with a thrombosis treated ≤30 days prior to the index
procedure

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

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