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Clinical trialNCT04647253Active, not recruitingPhase 3Interventional

A Clinical Trial to Assess the Agent Paclitaxel Coated PTCA Balloon Catheter for the Treatment of Subjects With In-Stent Restenosis (ISR)

SponsorBoston Scientific CorporationEnrollment600In-Stent Restenosis
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

AGENT IDE is a Prospective, Randomized (2:1), Multicenter Trial. The purpose of this study is to assess the safety and effectiveness of the Agent Paclitaxel Coated PTCA Balloon Catheter compared to balloon angioplasty (POBA) in patients with in-stent restenosis (ISR) of a previously treated lesion of up to 26 mm in length (by visual estimate) in a native coronary artery 2.0 mm to 4.0 mm in diameter.

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

40 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • University of Alabama at Birmingham

    Birmingham, Alabama, United States

  • Carondelet Medical Group St. Mary'S Hospital

    Tucson, Arizona, United States

  • University of California San Diego

    La Jolla, California, United States

  • Cedars Sinai Medical Center

    Los Angeles, California, United States

  • San Francisco Veterans Affairs Medical Center

    San Francisco, California, United States

  • Stanford University Medical Center

    Stanford, California, United States

  • St. Anthony Hospital

    Lakewood, Colorado, United States

  • South Denver Cardiology

    Littleton, Colorado, United States

  • Tallahassee Memorial Hospital

    Tallahassee, Florida, United States

  • Emory University Hospital

    Atlanta, Georgia, United States

  • Northside Hospital

    Lawrenceville, Georgia, United States

  • Wellstar Kennestone Hospital

    Marietta, Georgia, United States

  • Evanston Hospital

    Evanston, Illinois, United States

  • Overland Park Regional Medical Center

    Overland Park, Kansas, United States

  • Ochsner Medical Center

    New Orleans, Louisiana, United States

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, United States

  • Brigham and Women'S Hospital

    Boston, Massachusetts, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, United States

  • Tufts Medical Center

    Boston, Massachusetts, United States

  • Henry Ford Hospital

    Detroit, Michigan, United States

  • Regions Hospital

    Saint Paul, Minnesota, United States

  • St. Luke'S Hospital of Kansas City

    Kansas City, Missouri, United States

  • Bergan Cardiology

    Omaha, Nebraska, United States

  • Jersey Shore University Medical Center

    Neptune City, New Jersey, United States

  • Columbia University Medical Center

    New York, New York, United States

  • Montefiore Medical Center

    New York, New York, United States

  • St. Francis Hospital

    Roslyn, New York, United States

  • Wake Medical Center

    Raleigh, North Carolina, United States

  • Lindner Center for Research and Education at Christ Hospital

    Cincinnati, Ohio, United States

  • Cleveland Clinic Foundation

    Cleveland, Ohio, United States

  • Upmc Pinnacle Health

    Wormleysburg, Pennsylvania, United States

  • Rhode Island Hospital

    Providence, Rhode Island, United States

  • Methodist North Hospital

    Memphis, Tennessee, United States

  • Centennial Medical Center

    Nashville, Tennessee, United States

  • Heart Hospital of Austin

    Austin, Texas, United States

  • Baylor Heart and Vascular Hospital

    Dallas, Texas, United States

  • Houston Methodist Hospital

    Houston, Texas, United States

  • University of Virginia Medical Center

    Charlottesville, Virginia, United States

  • Inova Fairfax Hospital

    Falls Church, Virginia, United States

  • University of Washington

    Seattle, Washington, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
11 May 2021
Primary completion
2 Oct 2023
Completion
30 Sept 2027
Last update posted
17 Jul 2026
Registered enrollment
600
Registry id
NCT04647253

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.