IN.PACT™ AV Access Post-Approval Study (PAS002)

Primary Cohort Inclusion Criteria: * Patient is ≥ 21 years of age * Patient has a mature native AV fistula created ≥ 60 days prior to the index procedure * Patient has a de novo and/or non-stented restenotic lesion located between the arteriovenous anastomosis and axillosubclavian junction * Patient has a target lesion or a tandem lesion that is ≤ 100 mm in length (by visual estimate) Note: Tandem lesions may be included provided they meet all of the following criteria: a. Separated by a gap of ≤ 30 mm (3 cm), b. Total combined lesion length, including 30 mm gap, ≤ 100 mm, c. 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 PTA balloon defined as: Residual stenosis of ≤ 30% AND Absence of a flow limiting dissection or perforation AND No extravasation requiring treatment Primary Cohort 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 has an infected AV access or systemic infection * Patient with hemodynamically significant central venous stenoses that cannot be successfully treated prior to treatment of the target lesion * Patient with target lesion located central to the axillosubclavian junction * Patient has significant arterial inflow lesion requiring treatme…