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NCT04543539 · ClinicalTrials.gov registry record

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

A clinical trial of Arteriovenous Fistula and Fistula, sponsored by Medtronic.

Active
Registry status
240
Enrollment target
20
Study locations

NCT04543539 is a study of Arteriovenous Fistula and Fistula that is active but no longer recruiting, run by Medtronic. The registered enrollment target is 240 participants, roughly in line with the 230-participant average among 7 other Arteriovenous Fistula trials with a reported enrollment target. The trial reports 20 study locations across 15 states.

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The verdict

NCT04543539, a study of Arteriovenous Fistula and Fistula, is active but no longer recruiting, sponsored by Medtronic.

ACTIVE NOT RECRUITING
Registry status
240 participants
Enrollment target
20
Study locations

Study Summary

Long-term safety will be summarized

Interventions

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

Study Locations (20)

New York

  • Albany Medical College - Albany
  • The Mount Sinai Hospital - New York
  • Staten Island University Hospital - Staten Island

California

  • Cedars-Sinai Heart Institute - Los Angeles
  • Stanford University Medical Center - Stanford

Florida

  • NCH Healthcare System - Naples
  • Coastal Vascular and Interventional - Pensacola

South Carolina

  • MUSC Health Dialysis Access Institute - Orangeburg
  • Spartanburg Regional Medical Center - Spartanburg

Connecticut

  • Yale New Haven Hospital - New Haven

District of Columbia

  • Medstar Washington Hospital - Washington D.C.

Iowa

  • University of Iowa - Iowa City

Michigan

  • University of Michigan Health System - University Hospital - Ann Arbor

Trial Details

FieldValue
Enrollment Target 240 participants
Start Date 2020-11-13
Est. Completion 2029-02

Sponsor

Medtronic

30 total trials

What the Registry Record Tells You About NCT04543539

The ClinicalTrials.gov registry entry for NCT04543539 describes a study currently listed as active not recruiting, categorized as an unspecified phase. The registered enrollment target is 240 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 230-participant average among 7 other Arteriovenous Fistula trials with a reported enrollment target. The listed sponsor is Medtronic, which has 30 total studies on file at ClinicalTrials.gov.

The record links to 4 conditions, with Arteriovenous Fistula appearing as the primary indexed condition, and to 2 interventions - of which IN.PACT™ AV Drug Coated Balloon (DCB) - Primary Cohort is the first listed.

NCT04543539 reports 20 study locations spanning 15 distinct geographic areas - top geographies include New York, California, Florida.

Frequently Asked Questions

What is clinical trial NCT04543539 about?

NCT04543539 is a clinical study titled "IN.PACT™ AV Access Post-Approval Study (PAS002)". Long-term safety will be summarized

What is the current status of trial NCT04543539?

This trial is currently active not recruiting. The enrollment target is 240 participants. The study started on 2020-11-13. Estimated completion is 2029-02.

What conditions does trial NCT04543539 study?

This clinical trial studies the following conditions: Arteriovenous Fistula, Fistula, Arteriovenous Fistula Stenosis, Arteriovenous Fistula Occlusion.

What interventions are being tested in trial NCT04543539?

The interventions under investigation include: IN.PACT™ AV Drug Coated Balloon (DCB) - Primary Cohort (COMBINATION_PRODUCT), IN.PACT™ AV Drug Coated Balloon (DCB) - Extended Cohort (COMBINATION_PRODUCT).

Who is sponsoring clinical trial NCT04543539?

This trial is sponsored by Medtronic, which has 30 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04543539 being conducted?

This trial has 20 study locations across California, Connecticut, District of Columbia, Florida, Iowa. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.