A Prospective, Multi-center Study to Evaluate Efficacy and Safety of BSJ020R in Treatment of AVF for Hemodialysis (RANGER AV Japan Study)

Inclusion Criteria:

1. Subject is willing and able to provide consent before any study-specific tests orprocedures are performed and agree to attend all required follow-up visits.

2. Subject at least 18 years of age.

3. Subject has a native AV fistula created ≥ 60 days prior to enrollment.

4. The target AVF has undergone successful dialysis for at least 8 of 12 sessionsduring a four-week period prior to enrollment.

5. Subjects on stable dialysis has all of the following criteria meet.

• No significant decrease in blood pressure during dialysis during a four-weekperiod prior to enrollment

• No significant edema

• No signs of heart failure

6. Target lesion is located between the arteriovenous anastomosis and axillosubclavianjunction. Note: If the lesion is in the anastomosis, the treatment may be delivered up to 2 cmupstream on the arterial side. Note: If the lesion is in the cephalic arch, thetreatment may be delivered up to 2 cm into the subclavian vein.

7. Angiographic evidence that target lesion consists of a de novo and/or non-stentedrestenotic lesion with ≥ 50% stenosis by visual estimate.

8. Most recent standard PTA (ie. non-drug coated) treatment must be > 3 months priorto enrollment and most recent DCB treatment must be > 6 months prior toenrollment.

9. A target lesion with total lesion length up to 130 mm by visual estimate. Note:Tandem (or "adjacent") lesions may be enrolled provided they meet all of thefollowing criteria:

10. Separated by a gap of ≤ 30mm (3 cm).

11. Total combined lesion length, including 30 mm gap, is ≤ 130 mm.

12. Able to be treated as a single lesion.

13. Reference vessel diameter ≥ 4.0 mm and ≤ 8.0 mm by visual estimate.

14. Subject underwent successful crossing of the target lesion with the guide wire andpre-dilatation with only high pressure PTA balloon(s) defined as:

15. Residual stenosis of ≤ 30% AND.

16. Absence of a flow limiting dissection (Grade ≥ C) or perforation.

Exclusion Criteria:

1. Life expectancy, documented in the investigator's opinion, of less than 12 months.

2. Receiving immunosuppressive therapy.

3. Anticipating a kidney transplant within 6 months of enrollment into the study.

4. Patient with anticipated conversion to peritoneal dialysis.

5. Patient with AVF infection or systemic infection.

6. Patient has planned surgical revision of AVF.

7. Presence of secondary non-target lesion requiring treatment within 30-days postindex procedure.

8. Patient with hemodynamically significant central venous stenoses that cannot besuccessfully treated prior to treatment of the target lesion.

9. Patient with target AVF or access circuit which had within 1 year prior toenrollment or currently has a thrombosis.

10. Patients judged to have a lesion that prevents complete inflation of an angioplastyballoon or proper placement of the delivery system.

11. Target lesion located central to the axillosubclavian junction.

12. Patient has significant arterial inflow lesion requiring treatment more than 2 cmupstream from the anastomosis in the AVF.

13. Presence of aneurysm requiring treatment at the lesion site.

14. Presence of a stent or graft located in the target access circuit.

15. Known allergies or sensitivities to paclitaxel and/or raw materials of test devicesincluding ATBC (refer to Kiki-gaiyosho).

16. Known contraindication, including allergic reaction, or sensitivity to contrastmaterial that, in the opinion of the investigator, cannot be adequately pretreated.

17. Patient who cannot receive antiplatelet and/or anticoagulant therapy in accordancewith the investigator's direction.

18. Clinically significant Steal Syndrome requiring treatment.

19. Women who are breastfeeding, pregnant, or the subject with known intention toprocreate within 6 months after index procedure. Note: 6-month contraception afterindex procedure is required.

20. Subject is participating in another investigational drug or device clinical trialthat has not reached its primary endpoint, or subject was previously enrolled inthis study.

21. Subject intends to participate in another investigational drug or device clinicaltrial within 6 months after the index procedure.

22. Patient has a co-morbid condition that, in the opinion of the investigator, maycause him/her to be non-compliant with the protocol or confound the datainterpretation.