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Clinical trialNCT07045194RecruitingInterventional

Virtue® SAB in the Treatment of Coronary ISR Trial

SponsorOrchestra BioMed, IncEnrollment740Coronary Artery Disease
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

A prospective, multi-center, single-blind, randomized (1:1), non-inferiority study comparing clinical outcomes of the Virtue® Sirolimus AngioInfusion™ Balloon (SAB) to the AGENT™ Paclitaxel Drug-Coated Balloon (DCB) in the treatment of coronary artery in-stent restenosis (ISR).

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

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

United States
  • the Cardiac and Vascular Institute

    Gainesville, Florida, United States

    Recruiting
  • Ascension Sacred Heart

    Pensacola, Florida, United States

    Recruiting
  • Ascension St. Vincent

    Indianapolis, Indiana, United States

    Recruiting
  • Ascension Via Christi Saint Francis

    Wichita, Kansas, United States

    Recruiting
  • Ascension Saint Agnes Heart Care

    Baltimore, Maryland, United States

    Recruiting
  • Corewell Health William Beaumont University Hospital

    Royal Oak, Michigan, United States

    Recruiting
  • St. Francis Hospital

    Roslyn, New York, United States

    Recruiting
  • Mission Hospital

    Asheville, North Carolina, United States

    Recruiting
  • the Lindner Center for Research at Christ Hospital

    Cincinnati, Ohio, United States

    Recruiting
  • Thomas Jefferson University

    Philadelphia, Pennsylvania, United States

    Recruiting
  • Wellspan Health

    York, Pennsylvania, United States

    Recruiting
  • Ascension St. Thomas Hospital

    Nashville, Tennessee, United States

    Recruiting
  • Tristar Centennial Medical Center

    Nashville, Tennessee, United States

    Recruiting
  • Ascension Seton Hays

    Kyle, Texas, United States

    Recruiting
  • Ascension Columbia St. Mary'S Hospital

    Milwaukee, Wisconsin, United States

    Recruiting

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
20 Oct 2025
Primary completion
31 Oct 2028
Completion
31 Oct 2032
Last update posted
23 Jul 2026
Registered enrollment
740
Registry id
NCT07045194

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.