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IN.PACT™ AV Access Post-Approval Study (PAS002) | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITING

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

NCT04543539•Medtronic

View on ClinicalTrials.gov

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.

Eligibility

Age

21 - No limit years

Sex

ALL

Healthy Volunteers

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
•Patient is ≥ 21 years of age

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
+5 more criteria

Locations (20)

Cedars-Sinai Heart Institute

Los Angeles, California, United States

Stanford University Medical Center

Stanford, California, United States

Yale New Haven Hospital

New Haven, Connecticut, United States

Medstar Washington Hospital

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

NCH Healthcare System

Naples, Florida, United States

Coastal Vascular and Interventional

Pensacola, Florida, United States

University of Iowa

Iowa City, Iowa, United States

University of Michigan Health System - University Hospital

Ann Arbor, Michigan, United States

Mayo Clinic

Rochester, Minnesota, United States

Holy Name Medical Center

Teaneck, New Jersey, United States

Key Dates

Start Date

November 13, 2020

Primary Completion Date

June 3, 2025

Completion Date

February 1, 2029

Last Updated

October 20, 2025

Enrollment

240

ACTUAL participants

Conditions

Arteriovenous FistulaArteriovenous Fistula StenosisArteriovenous Fistula OcclusionFistula

Interventions

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

COMBINATION_PRODUCT

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

COMBINATION_PRODUCT

Post-market Surveillance Study of the BD® WavelinQ™ EndoAVF System

NCT04634916

Kidney Disease, End-StageEnd-stage Renal Disease+1 more

View study

RECRUITINGNA

Peripheral Scoring Drug-coated Balloon in the Treatment of Hemodialysis Arteriovenous Fistula Stenosis

NCT06422845

Arteriovenous Fistula Stenosis

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 20, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Post-market Surveillance Study of the BD® WavelinQ™ EndoAVF System

Peripheral Scoring Drug-coated Balloon in the Treatment of Hemodialysis Arteriovenous Fistula Stenosis

DRug-coAted Balloon Compared With cuttinG balloON in Treatment of Arteriovenous Fistula Stenosis

SelfWrap-Assisted Arteriovenous Fistulas

Safety and Efficacy Study of Human Umbilical Cord Mesenchymal Stem Cells in Preventing Arteriovenous Fistula Stenosis in Patients With End-Stage Diabetic Kidney Disease

Post Approval Study of the BARD® COVERA™ Arteriovenous (AV) Stent Graft