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 indexprocedure

• Patient has a de novo and/or non-stented restenotic lesion located between thearteriovenous anastomosis and axillosubclavian junction

• Patient has a target lesion or a tandem lesion that is ≤ 100 mm in length (by visualestimate) Note: Tandem lesions may be included provided they meet all of thefollowing criteria: a. Separated by a gap of ≤ 30 mm (3 cm), b. Total combinedlesion length, including 30 mm gap, ≤ 100 mm, c. Able to be treated as a singlelesion

• 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 andpre-dilatation with a PTA balloon defined as: Residual stenosis of ≤ 30% AND Absenceof a flow limiting dissection or perforation AND No extravasation requiringtreatment

Primary Cohort Exclusion Criteria:

• Women who are breastfeeding, pregnant, or are intending to become pregnant, or menintending 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 besuccessfully 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 treatment more than 2 cmupstream from the anastomosis in the AV access

• Patient has presence of pseudoaneurysm or aneurysm requiring treatment at the lesionsite

• Target lesion is located within a bare metal or covered stent

• Patients with known allergies or sensitivities to paclitaxel

• Patient with known contraindication, including allergic reaction, or sensitivity tocontrast material that cannot be adequately pre-treated

• Patient who cannot receive recommended antiplatelet and/or anticoagulant therapy

• Patient is enrolled in another investigational drug, device, or biologic study andhas not completed the primary endpoint, or was previously enrolled in this study

• Patient has a co-morbid condition that, in the judgment of the Investigator, maycause him/her to be non-compliant with the protocol or confound the datainterpretation

• Patient has an active COVID-19 infection with ongoing sequela at enrollment orhospitalization for treatment of COVID-19

Inclusion Criteria for Extended Cohort:

• Patient is ≥ 21 years of age

Exclusion Criteria for Extended Cohort:

• Patient has an active COVID-19 infection with ongoing sequela at enrollment orhospitalization for treatment of COVID-19