Recurrent Stenoses in Arteriovenous Fistula (AVF) for Dialysis Access: CuttIng ballooN angioplaSTy Combined wITh Paclitaxel drUg coaTed Balloon Angioplasty, an observatIONal Clinical Study

Inclusion criteria

• Recurrent stenoses (within 1 year after angioplasty) in the venous outflow of AVFs for dialysis access (> 0.5cm from AV anastomosis up to cephalic arch)
• Successful guidewire crossing of target lesion
• ≥ 21 years old
• Informed and valid consent given.
• Patient willing and able to return for follow up .

Exclusion criteria

• Thrombosed AVFs or occlusions in the access circuit
• Significant cephalic arch (central perpendicular portion of the cephalic vein) or central vein stenoses.
• > 3 stenosed segments (lesions are considered separate if they are separated by at least 2 cm normal vessel.)
• Only potential target lesion located in cephalic arch, central veins or anastomotic lesions.
• Only de novo stenoses identifiable as target lesion.
• Target lesion resistant to cutting balloon angioplasty (>30% residual stenosis with incomplete effacement of the lesion during cutting balloon angioplasty)
• Target lesion not treatable with the available sizes of cutting balloon (4-7mm) and drug eluting balloon (up to 8mm) so native reference vessel <3 mm or need for DEB balloon >8mm.
• Lesion in excess of 8 cm
• Unable to take dual antiplatelet therapy for 1 month and/or aspirin for 6 months
• Coagulopathy (PT or PTT >1.5 times the median of normal range) or thrombocytopenia (platelet count <50,000 /μL) that cannot be managed adequately with periprocedural transfusion.
• Patient on Warfarin.
• Known allergy to iodinated contrast that cannot be managed adequately with pre-procedure medication.
• Allergy / contraindication to dual anti-platelet therapy (aspirin and clopidogrel or ticlopidine) or paclitaxel.
• Acute infection over proposed puncture site.
• Women who are breastfeeding, pregnant or planning on becoming pregnant during study.
• Participant with medical conditions, which in the opinion of the investigator may cause non-compliance with protocol.
• Currently participating in an investigational drug, biologic or device trial that may have an impact on the dialysis access or previous enrolment in this study.