IN.PACT™ AV Access IDE Study

Inclusion Criteria

• Patient is ≥21 years of age.
• Patient has a life expectancy of ≥ 12 months
• Patient has a native AV fistula created ≥ 60 days prior to the index procedure
• The target AV fistula has undergone successful dialysis for at least 8 of 12 sessions during a four week period
• 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
• 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
• Patient has a target vessel diameter of 4.0 - 12.0 mm (by visual estimate).
• 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
• Patient provides written consent prior to enrollment in the study
• Patient is willing to comply with all follow-up evaluations at specified times

Exclusion Criteria

• Women who are breastfeeding, pregnant, or are intending to become pregnant, or men intending to father children
• Patient is receiving immunosuppressive therapy
• Patient is anticipating a kidney transplant within 6 months of enrollment into the study
• Patient has undergone prior intervention of access site within 30 days of index procedure
• Patient with anticipated conversion to peritoneal dialysis
• Patient has an infected AV access or systemic infection
• Patient has planned surgical revision of access site
• Patient with secondary non-target lesion requiring treatment within 30-days post index procedure
• Patient with hemodynamically significant central venous stenoses that cannot be successfully treated prior to treatment of the target lesion
• Patient with target AVF or access circuit which previously had or currently has a thrombosis
• Patients judged to have a lesion that prevents complete inflation of an angioplasty balloon or proper placement of the delivery system
• Patient with target lesion located central to the axillosubclavian junction
• Patient has significant arterial inflow lesion requiring treatment more than 2 cm upstream from the anastomosis in the AV access
• Patient has presence of pseudoaneurysm or aneurysm requiring treatment at the lesion site
• Patient has presence of a stent located in the target AV access circuit
• Patients with known allergies or sensitivities to paclitaxel
• Patient with known contraindication, including allergic reaction, or sensitivity to contrast material that cannot be adequately pre-treated
• Patient who cannot receive recommended antiplatelet and/or anticoagulant therapy
• Patient with clinically significant Steal Syndrome requiring treatment
• 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
• 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