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 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.