MAgicTouch™ Intervention Leap for Dialysis Access (MATILDA) Trial

Inclusion Criteria: * Informed consent was obtained * Patient aged ≥ 21 and ≤ 90 years * Native AVF was created more than 2 months prior to index procedure and had undergone 10 or more haemodialysis sessions utilizing two needles * Target lesion location had to be located between the anastomoses to the axillary-subclavian vein junction, as defined by insertion of the cephalic vein * On initial fistulogram, target lesions stenosis had to be ≥50 on angiographic assessment and in keeping with the clinical indicator for intervention * Stenosis had to \<12cm in length (to allow for potential treatment with one SCB (length 15cm) only * Stenosis had to be initially treated successfully with a high-pressure plain balloon prior to SCB treatment as defined by:- (A) no clinically significant dissection (flow limiting) (B) no extravasation requiring treatment/stenting (C) residual stenosis ≤30% by angiographic measurement (D) Ability to completely efface the lesion waist using the pre-dilation balloon * No more than one additional ("nontarget") lesion in the access circuit that had to be also successfully treated (≤30% residual stenosis) before drug elution. Separate lesion was defined by at least 3cm in distance from the target lesion. * Reference vessel diameter 5mm-8mm Exclusion Criteria: * Women who were preganant, lactating, or planning on becoming pregnant during the study * Subject had more than 2 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 index procedure * Surgical revision of the access site performed, planned or expected ≤ 3months before or after the index procedure * Patients who were taking immunosuppressive therapy or are routinely taking ≥15 mg prednisone per day * Currently participating in 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 know contraindication to iodinated media contrast, heparin, or Sirolimus