RecruitingNot ApplicableNCT06959524

AGENT DCB STANCE: Safety and Effectiveness Study of AGENT Drug-Coated Balloon Compared to Standard of Care Percutaneous Coronary Intervention (PCI) Treatment for de Novo Coronary Lesions

AGENT DCB STANCE: AGENT Drug-Coated Balloon for STent AvoidANCE in PCI for De Novo Coronary Artery Disease

Sponsor

Boston Scientific Corporation

Enrollment

1,616 participants

Start Date

Aug 21, 2025

Study Type

INTERVENTIONAL

Conditions

Coronary Arterial Disease (CAD)de Novo Lesions in Native Coronary Arteries

Summary

AGENT DCB STANCE is a prospective, multicenter, open-label, 1:1 randomized controlled study designed to assess the safety and effectiveness of a treatment strategy with the AGENT Drug-Coated Balloon compared to standard of care percutaneous coronary intervention (PCI) treatment with drug eluting stent (DES) and/or balloon angioplasty in patients with de novo coronary lesions. Subjects must have a de novo target lesion located in a native coronary artery.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Drug Eluting Balloon, a medical device called Drug eluting stent, and others for people with coronary arterial disease (cad) and de novo lesions in native coronary arteries. The study is currently recruiting participants at 55 locations.

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

DEVICEDrug Eluting Balloon

AGENT DCB

DEVICEDrug eluting stent

Any commercially available DES used for standard of care.

PROCEDUREPlain old balloon angioplasty

Bifurcation side branch - POBA

Locations(62)

Scripps Memorial Hospital

La Jolla, California, United States

USC Medical Center

Los Angeles, California, United States

Cedars - Sinai Medical Center

Los Angeles, California, United States

University of California San Francisco

San Francisco, California, United States

Stanford University Medical Center

Stanford, California, United States

Los Robles Hospital & Medical Center

Thousand Oaks, California, United States

South Denver Cardiology Associates, PC

Littleton, Colorado, United States

The Cardiac and Vascular Institute Research Foundation

Gainesville, Florida, United States

Mount Sinai Medical Center

Miami Beach, Florida, United States

Piedmont Hospital

Atlanta, Georgia, United States

Emory University Hospital

Atlanta, Georgia, United States

Wellstar Kennestone Hospital

Marietta, Georgia, United States

Endeavor Health

Glenview, Illinois, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

University of Michigan Hospitals

Ann Arbor, Michigan, United States

Henry Ford Hospital

Detroit, Michigan, United States

Corewell Health

Grand Rapids, Michigan, United States

Mercy Hospital

Coon Rapids, Minnesota, United States

St. Luke's Hospital of Kansas City

Kansas City, Missouri, United States

NYU Langone Hospital

Brooklyn, New York, United States

Mount Sinai Medical Center

New York, New York, United States

Columbia University Medical Center

New York, New York, United States

St. Francis Hospital

Roslyn, New York, United States

Montefiore Medical Center

The Bronx, New York, United States

Carolinas Medical Center

Charlotte, North Carolina, United States

Lindner Center for Research and Education at Christ Hospital

Cincinnati, Ohio, United States

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Ohio Health Riverside Methodist Hospital

Columbus, Ohio, United States

Providence St. Vincent Medical Center

Portland, Oregon, United States

UPMC Pinnacle

Mechanicsburg, Pennsylvania, United States

York Hospital

York, Pennsylvania, United States

Rhode Island Hospital

Providence, Rhode Island, United States

Prisma Health Richland Hospital

Columbia, South Carolina, United States

Heart Hospital of Austin

Austin, Texas, United States

Baylor Heart & Vascular Hospital

Dallas, Texas, United States

The Methodist Hospital Research Institute

Houston, Texas, United States

The Heart Hospital Baylor Plano

Plano, Texas, United States

Methodist Healthcare System of San Antonio dba Methodist Hospital

San Antonio, Texas, United States

University of Virginia Medical Center

Charlottesville, Virginia, United States

Inova Fairfax Hospital

Falls Church, Virginia, United States

Charleston Area Medical Center

Charleston, West Virginia, United States

The Prince Charles Hospital

Chermside, Queensland, Australia

Victorian Heart Hospital

Clayton, Victoria, Australia

Beijing Anzhen Hospital of the Capital University of Medical Sciences

Beijing, Beijing Municipality, China

Fuwai Hospital Chinese Academy of Medical Sciences

Beijin, Beijin, China

The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangzhou, China

Wuhan Asia Heart Hospital

Wuhan, Hubei, China

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, China

Cellitinnen Krankenhaus St. Vinzenz

Cologne, Germany

MEDICLIN Herzzentrum Lahr

Lahr, Germany

Mater Private Hospital Cork

Cork, Ireland

Mater Private Hospital

Dublin, Ireland

Galway University Hospital

Galway, Ireland

Medical Corporation Sapporo Heart Center Sapporo Cardiovascular Clinic

Sapporo, Hokkaido, Japan

Chikamori Hospital

Kochi, Japan

Auckland City Hospital

Auckland, New Zealand

Samsung Medical Center

Seoul, South Korea

Hospital Universitario de La Princesa

Madrid, Spain

Hospital Universitario y Politécnico La Fe

Valencia, Spain

Clínico de Valladolid

Valladolid, Spain

View Full Details on ClinicalTrials.gov

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NCT06959524

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