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

Medtronic

Status: Active, not recruiting

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

Treatments: Combination Product: IN.PACT™ AV Drug Coated Balloon (DCB) - Extended Cohort; Combination Product: IN.PACT™ AV Drug Coated Balloon (DCB) - Primary Cohort

Study type: Observational

Funder types: Industry

Identifiers

NCT04543539

IN.PACT™ AV Access PAS002

Details and patient eligibility

About

Long-term safety will be summarized

Full description

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.

Enrollment: 240 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

240 participants in 2 patient groups

IN.PACT™ AV Access PAS Primary Cohort

Description:

The primary cohort consists of enrolled subjects treated with the IN.PACT™ AV DCB according to labeling requirements who meet the inclusion/exclusion criteria for the primary cohort.

Treatment:

Combination Product: IN.PACT™ AV Drug Coated Balloon (DCB) - Primary Cohort

IN.PACT™ AV Access PAS Extended Cohort

Description:

The extended cohort consists of enrolled subjects who do not meet the eligibility criteria for the primary cohort and receive the IN.PACT™ AV DCB device for treatment of stenosis in the AV circuit.

Treatment:

Combination Product: IN.PACT™ AV Drug Coated Balloon (DCB) - Extended Cohort