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

Exclusion Criteria

• •1. Thrombosed AVFs or occlusions in the access circuit
• •2. Significant cephalic arch (central perpendicular portion of the cephalic vein) or central vein stenoses.
• •3. \> 3 stenosed segments (lesions are considered separate if they are separated by at least 2 cm normal vessel.)
• •4. Only potential target lesion located in cephalic arch, central veins or anastomotic lesions.
• •5. Only de novo stenoses identifiable as target lesion.
• •6. Target lesion resistant to cutting balloon angioplasty (\>30% residual stenosis with incomplete effacement of the lesion during cutting balloon angioplasty)
• •7. 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.
• •8. Lesion in excess of 8 cm
• •9. Unable to take dual antiplatelet therapy for 1 month and/or aspirin for 6 months
• •10. 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.
• •11. Patient on Warfarin.
• •12. Known allergy to iodinated contrast that cannot be managed adequately with pre-procedure medication.
• •13. Allergy / contraindication to dual anti-platelet therapy (aspirin and clopidogrel or ticlopidine) or paclitaxel.
• •14. Acute infection over proposed puncture site.
• •15. Women who are breastfeeding, pregnant or planning on becoming pregnant during study.
• •16. Participant with medical conditions, which in the opinion of the investigator may cause non-compliance with protocol.
• •17. 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.