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

NCT04543539 | Active Not Recruiting FDA Device

• 1 other identifier: IN.PACT™ AV Access PAS002
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 20

Brief Summary

Long-term safety will be summarized

Conditions

Arteriovenous Fistula; Arteriovenous Fistula Stenosis; Arteriovenous Fistula Occlusion; Fistula

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Mortality Rate

  Through 1, 2, 3, 4, and 5 years post-index procedure

Other Outcomes (1)

• Extended Cohort - Characterize Infections and Infestations Serious Adverse Events

  Through 1-year and all-cause mortality through 5-years post-index procedure

Study Arms (2)

IN.PACT™ AV Access PAS 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.

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

IN.PACT™ AV Access PAS 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.

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

Interventions

IN.PACT™ AV Drug Coated Balloon (DCB) - Primary Cohort COMBINATION_PRODUCT

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.

IN.PACT™ AV Access PAS Primary Cohort

IN.PACT™ AV Drug Coated Balloon (DCB) - Extended Cohort COMBINATION_PRODUCT

For treatment of stenosis in the AV circuit

IN.PACT™ AV Access PAS Extended Cohort

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population includes patients that will have an angioplasty with the IN.PACT™ AV Paclitaxel-Coated PTA Balloon Catheter (IN.PACT™ AV DCB).

You may qualify if:

• 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

You may not qualify if:

• 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
• Patient is ≥ 21 years of age

Sponsors & Collaborators

• Medtronic: lead

Study Sites (20)

Cedars-Sinai Heart Institute

Los Angeles, California, 90048, United States

Location

Stanford University Medical Center

Stanford, California, 94301, United States

Location

Yale New Haven Hospital

New Haven, Connecticut, 06519, United States

Location

Medstar Washington Hospital

Washington D.C., District of Columbia, 20010, United States

Location

NCH Healthcare System

Naples, Florida, 34102, United States

Location

Coastal Vascular and Interventional

Pensacola, Florida, 32504, United States

Location

University of Iowa

Iowa City, Iowa, 52242, United States

Location

University of Michigan Health System - University Hospital

Ann Arbor, Michigan, 48109, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Holy Name Medical Center

Teaneck, New Jersey, 07666, United States

Location

Albany Medical College

Albany, New York, 12084, United States

Location

The Mount Sinai Hospital

New York, New York, 10029, United States

Location

Staten Island University Hospital

Staten Island, New York, 10305, United States

Location

FirstHealth of the Carolinas

Pinehurst, North Carolina, 28374, United States

Location

Oregon Health & Science University Hospital

Portland, Oregon, 97239, United States

Location

Lancaster General Hospital

Lancaster, Pennsylvania, 17602, United States

Location

MUSC Health Dialysis Access Institute

Orangeburg, South Carolina, 29118, United States

Location

Spartanburg Regional Medical Center

Spartanburg, South Carolina, 29303, United States

Location

University of Virginia Medical Center

Charlottesville, Virginia, 22903, United States

Location

University of Wisconsin-Madison - Meriter Hospital

Madison, Wisconsin, 53713, United States

Location

MeSH Terms

Conditions

Arteriovenous Fistula; Fistula

Condition Hierarchy (Ancestors)

Arteriovenous Malformations; Vascular Malformations; Cardiovascular Abnormalities; Cardiovascular Diseases; Vascular Fistula; Vascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2020
• First Posted: September 10, 2020
• Study Start: November 13, 2020
• Primary Completion: June 3, 2025
• Study Completion (Estimated): February 1, 2029
• Last Updated: October 20, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (20)