Use of Implanting the Biotronik Passeo-18 Lux Drug Coated Balloon to Treat Failing Haemodialysis Arteriovenous Fistulas and Grafts.

Inclusion Criteria: * Patient aged ≥21 years and ≤90 years * Native AVF was created more than 2 months prior to the index procedure and had undergone 10 or more hemodialysis sessions utilizing 2 needles * Target lesion location had to be located between the anastomosis to the axillary-subclavian vein junction, as defined by insertion of the cephalic vein. * On initial fistulogram, target lesion stenosis had to be \>50% on angiographic assessment and in keeping with the clinical indicator for intervention * Stenosis had to be \< 10cm in length to allow for potential treatment with one PCB (length 12 cm) only * Stenosis had to be initially treated successfully with a high-pressure plain balloon prior to PCB treatment as defined by: 1. No clinically significant dissection 2. No extravasation requiring treatment/stenting 3. Residual stenosis ≤20% by angiographic measurement 4. Ability to completely efface the lesion waist using the pre-dilation balloon * No more than one additional ("nontarget") lesions in the access circuit that had to be also successfully treated (≤30% residual stenosis) before drug elution. Separate lesion was defined by at least 3 cm in distance from the target lesion. * Reference vessel diameter 4mm - 8mm Exclusion Criteria: * Women who were pregnant, lactating, or planning on becoming pregnant during the study * Subject had more than two lesions in the access circuit * Subject had a secondary non-target lesion that could not be successfully treated * Sepsis or active infection * Asymptomatic target lesions * A thrombosed access or an access with thrombosis treated ≤30 days prior to the index procedure * Surgical revision of the access site performed, planned or expected ≤ 3 months before or after the index procedure * Patients who were taking immunosuppressive therapy or are routinely taking ≥ 15 mg of prednisone per day; * Currently participating in an another investigational drug, biologic, or device study involving sirolimus or paclitaxel * Contraindication to aspirin or clopidogrel usage * Mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study, or language barrier such that the subject is unable to give informed consent * Uncooperative attitude or potential for non-compliance with the requirements of the protocol making study participation impractical * Where final angioplasty treatment requires a stent or drug eluting balloon \> 8mm in diameter * Metastatic cancer or terminal medical condition * Blood coagulation disorders * Limited life expectancy (\< 12 months) * Allergy or other known contraindication to iodinated media contrast, heparin or paclitaxel