IN.PACT™ AV Access IDE Study

Randomized Study of IN.PACT™ AV Access Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon vs. Standard PTA for the Treatment of Obstructive Lesions in the Native Arteriovenous Dialysis Fistulae (AVF)

To evaluate the safety and efficacy of the IN.PACT™ AV Access Drug Coated Balloon (DCB) compared to percutaneous transluminal angioplasty (PTA) for treatment of subjects presenting with de novo or non-stented restenotic obstructive lesion of native arteriovenous dialysis fistulae (AVF) in the upper extremity.

This is a prospective, global, multi-center, single-blinded, 1:1 randomized clinical trial evaluating the IN.PACT™ AV Access Drug Coated Balloon (DCB) compared to percutaneous transluminal angioplasty (PTA) for treatment of subjects presenting with de novo or non-stented restenotic obstructive lesion of native arteriovenous dialysis fistulae (AVF) in the upper extremity. The trial will be conducted in up to 30 sites in the United States, Japan, and New Zealand.

Inclusion Criteria:

1. Patient is ≥21 years of age.
2. Patient has a life expectancy of ≥ 12 months
3. Patient has a native AV fistula created ≥ 60 days prior to the index procedure
4. The target AV fistula has undergone successful dialysis for at least 8 of 12 sessions during a four week period
5. Patient has a de novo and/or non-stented restenotic lesion located between the arteriovenous anastomosis and axillosubclavian junction with ≥50% stenosis. Note: If the lesion is located in the anastomosis, the treatment may be delivered up to 2 cm upstream on the arterial side. If the lesion is located in the cephalic arch, the treatment may be delivered up to 2 cm into the subclavian vein
6. Patient has a target lesion or a tandem lesion that is ≤ 100 mm in length (by visual estimate) Note: Tandem lesions may be enrolled provided they meet all of the following criteria: Separated by a gap of ≤ 30mm (3 cm), total combined lesion length, including 30 mm gap, ≤ 100 mm, and able to be treated as a single lesion
7. Patient has a target vessel diameter of 4.0 - 12.0 mm (by visual estimate).
8. Patient underwent successful crossing of the target lesion with the guide wire and pre-dilatation with a high pressure PTA balloon defined as: residual stenosis of ≤ 30% and absence of a flow limiting dissection (Grade ≥ C) or perforation
9. Patient provides written consent prior to enrollment in the study
10. Patient is willing to comply with all follow-up evaluations at specified times

Exclusion Criteria:

1. Women who are breastfeeding, pregnant, or are intending to become pregnant, or men intending to father children
2. Patient is receiving immunosuppressive therapy
3. Patient is anticipating a kidney transplant within 6 months of enrollment into the study
4. Patient has undergone prior intervention of access site within 30 days of index procedure
5. Patient with anticipated conversion to peritoneal dialysis
6. Patient has an infected AV access or systemic infection
7. Patient has planned surgical revision of access site
8. Patient with secondary non-target lesion requiring treatment within 30-days post index procedure
9. Patient with hemodynamically significant central venous stenoses that cannot be successfully treated prior to treatment of the target lesion
10. Patient with target AVF or access circuit which previously had or currently has a thrombosis
11. Patients judged to have a lesion that prevents complete inflation of an angioplasty balloon or proper placement of the delivery system
12. Patient with target lesion located central to the axillosubclavian junction
13. Patient has significant arterial inflow lesion requiring treatment more than 2 cm upstream from the anastomosis in the AV access
14. Patient has presence of pseudoaneurysm or aneurysm requiring treatment at the lesion site
15. Patient has presence of a stent located in the target AV access circuit
16. Patients with known allergies or sensitivities to paclitaxel
17. Patient with known contraindication, including allergic reaction, or sensitivity to contrast material that cannot be adequately pre-treated
18. Patient who cannot receive recommended antiplatelet and/or anticoagulant therapy
19. Patient with clinically significant Steal Syndrome requiring treatment
20. Patient is enrolled in another investigational drug, device, or biological study and has not completed the primary endpoint, or was previously enrolled in this study
21. Patient has a comorbid-condition that, in the judgment of the Investigator, may cause him/her to be non-compliant with the protocol of confound data interpretation