in.pact™ av access post-approval study (pas002)

Conditions: Arteriovenous Fistula; Arteriovenous Fistula Stenosis; Arteriovenous Fistula Occlusion; Fistula

Summary: long-term safety will be summarized

the purpose of this study is to evaluate the long-term safety of the in.pact™ av access drug coated balloon (dcb) for treatment of subjects presenting with de novo or non-stented restenotic obstructive lesion of native arteriovenous dialysis fistulae (avf) in the upper extremity. patients will be followed for five years. the in.pact™ av access pas 002 is required by the food and drug administration (fda) as a condition of product approval. this study is conducted within medtronic's post market surveillance platform.

Eligibility criteria:
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