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

Active, not recruiting

• Conditions: Arteriovenous Fistula; Arteriovenous Fistula Occlusion; Arteriovenous Fistula Stenosis; Fistula
• Interventions: Combination Product: IN.PACT™ AV Drug Coated Balloon (DCB) - Primary Cohort; Combination Product: IN.PACT™ AV Drug Coated Balloon (DCB) - Extended Cohort

• Registration Number: NCT04543539
• Lead Sponsor: Medtronic

Brief Summary

Long-term safety will be summarized

Detailed 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.

Study Timeline

• Study First Submitted: 2020-09-02
• Study First Submitted QC: 2020-09-02
• Study First Posted: 2020-09-10
• Study Start: 2020-11-13
• Status Verified: 2024-07
• Last Update Submitted: 2025-04-06
• Last Update Posted: 2025-04-08
• Primary Completion: 2025-06
• Study Completion: 2029-02

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 240

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
IN.PACT™ AV Access PAS Primary Cohort	IN.PACT™ AV Drug Coated Balloon (DCB) - Primary Cohort	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.
IN.PACT™ AV Access PAS Extended Cohort	IN.PACT™ AV Drug Coated Balloon (DCB) - Extended Cohort	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Mortality Rate	Through 1, 2, 3, 4, and 5 years post-index procedure	Determine mortality rate

Trial Locations

Locations (20)

Staten Island University Hospital; 🇺🇸 Staten Island, New York, United States

Cedars-Sinai Heart Institute; 🇺🇸 Los Angeles, California, United States

Medstar Washington Hospital; 🇺🇸 Washington D.C., District of Columbia, United States

University of Michigan Health System - University Hospital; 🇺🇸 Ann Arbor, Michigan, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

The Mount Sinai Hospital; 🇺🇸 New York, New York, United States

FirstHealth of the Carolinas; 🇺🇸 Pinehurst, North Carolina, United States

Oregon Health & Science University Hospital; 🇺🇸 Portland, Oregon, United States

Lancaster General Hospital; 🇺🇸 Lancaster, Pennsylvania, United States

Stanford University Medical Center; 🇺🇸 Stanford, California, United States

Coastal Vascular and Interventional; 🇺🇸 Pensacola, Florida, United States

Yale New Haven Hospital; 🇺🇸 New Haven, Connecticut, United States

Holy Name Medical Center; 🇺🇸 Teaneck, New Jersey, United States

Albany Medical College; 🇺🇸 Albany, New York, United States

NCH Healthcare System; 🇺🇸 Naples, Florida, United States

University of Iowa; 🇺🇸 Iowa City, Iowa, United States

MUSC Health Dialysis Access Institute; 🇺🇸 Orangeburg, South Carolina, United States

Spartanburg Regional Medical Center; 🇺🇸 Spartanburg, South Carolina, United States

University of Virginia Medical Center; 🇺🇸 Charlottesville, Virginia, United States

University of Wisconsin-Madison - Meriter Hospital; 🇺🇸 Madison, Wisconsin, United States