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

Eligibility 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 K/DOQI 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.
• 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. Target lesion is located central to the axillosubclavian junction
• 5. A thrombosed access or an access with a thrombosis treated ≤7 days before to the index 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