IN.PACT™ AV Access Post-Approval Study (PAS002)
Recruitment Status: Recruiting
Start Date: November 13, 2020
End Date: February 01, 2029
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
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Conditions:
- Arteriovenous Fistula
- Fistula