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

Study Overview
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Brief Summary
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Long-term safety will be summarized

Detailed Description
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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.

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

Conditions
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Arteriovenous Fistula, Arteriovenous Fistula Stenosis, Arteriovenous Fistula Occlusion, Fistula

Intervention / Treatment
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* Combination Product: IN.PACT™ AV Drug Coated Balloon (DCB) - Primary Cohort
* Combination Product: IN.PACT™ AV Drug Coated Balloon (DCB) - Extended Cohort


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| IN.PACT™ AV Access PAS Primary Cohort<br>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. | Combination Product: IN.PACT™ AV Drug Coated Balloon (DCB) - Primary Cohort<br>* For the treatment of obstructive lesions up to 100 mm in length in the native arteriovenous dialysis fistulae with reference vessel diameters of 4 to 12 mm.<br>|
| IN.PACT™ AV Access PAS Extended Cohort<br>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. | Combination Product: IN.PACT™ AV Drug Coated Balloon (DCB) - Extended Cohort<br>* For treatment of stenosis in the AV circuit<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infection and Infestations Serious Adverse Events | Demonstrate Infection and Infestations Serious Adverse Events, including pneumonia, meets the performance goal of 30% in the primary cohort. | Through 12 months post-index procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality Rate | Determine mortality rate | Through 1, 2, 3, 4, and 5 years post-index procedure |