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

IN.PACT™ AV Access PAS002

Long-term safety will be summarized

2020-11-13

2025-02-01

2029-02-01

Recruiting

240

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 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 * 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 to contrast 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 and has 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, may cause him/her to be non-compliant with the protocol or confound the data interpretation * Patient has an active COVID-19 infection with ongoing sequela at enrollment or hospitalization 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 or hospitalization for treatment of COVID-19

{'studyType': 'OBSERVATIONAL', 'patientRegistry': True, 'targetDuration': '5 Years', 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 240, 'type': 'ESTIMATED'}}

2024-02-14