RecruitingNot ApplicableNCT07045194

Virtue® SAB in the Treatment of Coronary ISR Trial

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).

Sponsor

Orchestra BioMed, Inc

Enrollment

740 participants

Start Date

Oct 20, 2025

Study Type

INTERVENTIONAL

Conditions

Coronary Artery Disease

Summary

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).

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called AGENT™ Paclitaxel Drug-Coated Balloon and a medical device called Virtue Sirolimus AngioInfusion Balloon for people with coronary artery disease. The study is currently recruiting participants at 2 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEVirtue Sirolimus AngioInfusion Balloon

Percutaneous Coronary Intervention

DEVICEAGENT™ Paclitaxel Drug-Coated Balloon

Percutaneous Coronary Intervention

Locations(15)

The Cardiac and Vascular Institute

Gainesville, Florida, United States

Ascension Sacred Heart

Pensacola, Florida, United States

Ascension St. Vincent

Indianapolis, Indiana, United States

Ascension Via Christi Saint Francis

Wichita, Kansas, United States

Ascension Saint Agnes Heart Care

Baltimore, Maryland, United States

Corewell Health William Beaumont University Hospital

Royal Oak, Michigan, United States

St. Francis Hospital

Roslyn, New York, United States

Mission Hospital

Asheville, North Carolina, United States

The Lindner Center for Research at Christ Hospital

Cincinnati, Ohio, United States

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

WellSpan Health

York, Pennsylvania, United States

TriStar Centennial Medical Center

Nashville, Tennessee, United States

Ascension St. Thomas Hospital

Nashville, Tennessee, United States

Ascension Seton Hays

Kyle, Texas, United States

Ascension Columbia St. Mary's Hospital

Milwaukee, Wisconsin, United States

View Full Details on ClinicalTrials.gov

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NCT07045194

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