Could a balloon replace stents for clogged heart arteries?

NCT ID NCT06959524

Recruiting now Disease control Sponsor: Boston Scientific Corporation Source: ClinicalTrials.gov ↗

First seen Jun 24, 2026 · Last updated Jul 31, 2026 · Updated 4 times

Summary

This study tests whether a drug-coated balloon can be a safe and effective alternative to stents for treating new blockages in heart arteries. About 1,616 people will be randomly assigned to receive either the balloon or standard stent treatment. The goal is to see if the balloon can avoid the need for a permanent implant while keeping arteries open.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: drug-coated balloon (AGENT DCB)
What this could lead to: If successful, this could offer a stent-free option for treating blocked heart arteries, potentially reducing long-term complications from permanent implants.
What could go wrong: This is an early-stage study with no phase designation, so results are uncertain. The balloon may not work as well as stents for keeping arteries open, and there is a risk of heart attack or need for repeat procedures.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Get updates

Get notified about this study

Our safety recommendation!

By submitting, you agree to our Terms of use

Conditions

The condition(s) this trial relates to.

coronary artery disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

CORONARY ARTERIAL DISEASE (CAD) DE NOVO LESIONS IN NATIVE CORONARY ARTERIES

Contacts and locations

Show contact details

Locations

Auckland City Hospital
RECRUITING

Auckland, 1010, New Zealand
Baylor Heart & Vascular Hospital
RECRUITING

Dallas, Texas, 75226, United States
Beijing Anzhen Hospital of the Capital University of Medical Sciences
RECRUITING

Beijing, Beijing Municipality, 100000, China

Contact Email: •••••@•••••
Beth Israel Deaconess Medical Center
RECRUITING

Boston, Massachusetts, 02215, United States
Brigham and Women's Hospital
RECRUITING

Boston, Massachusetts, 02115, United States
Carolinas Medical Center
RECRUITING

Charlotte, North Carolina, 28204, United States
Cedars - Sinai Medical Center
RECRUITING

Los Angeles, California, 90048, United States
Cellitinnen Krankenhaus St. Vinzenz
RECRUITING

Cologne, 50733, Germany
Charleston Area Medical Center
RECRUITING

Charleston, West Virginia, 25304, United States
Chikamori Hospital
RECRUITING

Kochi, 780-8522, Japan
Cleveland Clinic Foundation
RECRUITING

Cleveland, Ohio, 44195, United States
Clínico de Valladolid
RECRUITING

Valladolid, 47012, Spain
Columbia University Medical Center
RECRUITING

New York, New York, 10032, United States
Corewell Health
RECRUITING

Grand Rapids, Michigan, 49503, United States
Emory University Hospital
RECRUITING

Atlanta, Georgia, 30322, United States
Endeavor Health
RECRUITING

Glenview, Illinois, 60026, United States
Fuwai Hospital Chinese Academy of Medical Sciences
RECRUITING

Beijin, Beijin, 100000, China
Galway University Hospital
RECRUITING

Galway, H91 YR71, Ireland
Heart Hospital of Austin
WITHDRAWN

Austin, Texas, 78705, United States
Henry Ford Hospital
RECRUITING

Detroit, Michigan, 48202, United States
Hospital Universitario de La Princesa
RECRUITING

Madrid, 28006, Spain
Hospital Universitario y Politécnico La Fe
RECRUITING

Valencia, 46026, Spain
Inova Fairfax Hospital
RECRUITING

Falls Church, Virginia, 22042, United States
Krankenhaus der Barmherzigen Brüder
RECRUITING

Trier, 54292, Germany
Kyorin University Hospital
RECRUITING

Mitaka, Tokyo, 181-8611, Japan
Lindner Center for Research and Education at Christ Hospital
RECRUITING

Cincinnati, Ohio, 45219, United States
Los Robles Hospital & Medical Center
RECRUITING

Thousand Oaks, California, 91360, United States
MEDICLIN Herzzentrum Lahr
RECRUITING

Lahr, 77933, Germany
Massachusetts General Hospital
RECRUITING

Boston, Massachusetts, 02114, United States
Mater Private Hospital
RECRUITING

Dublin, D07 RD8P, Ireland
Mater Private Hospital Cork
RECRUITING

Cork, T12 K199, Ireland
Medical Corporation Sapporo Heart Center Sapporo Cardiovascular Clinic
RECRUITING

Sapporo, Hokkaido, 007-0849, Japan
Mercy Hospital
RECRUITING

Coon Rapids, Minnesota, 55433, United States
Methodist Healthcare System of San Antonio dba Methodist Hospital
RECRUITING

San Antonio, Texas, 78229, United States
Montefiore Medical Center
RECRUITING

The Bronx, New York, 10467, United States
Mount Sinai Medical Center
RECRUITING

Miami Beach, Florida, 33140, United States
Mount Sinai Medical Center
RECRUITING

New York, New York, 10029, United States
NYU Langone Hospital
RECRUITING

Brooklyn, New York, 11220, United States
Northwestern University
RECRUITING

Evanston, Illinois, 60208, United States
Ohio Health Riverside Methodist Hospital
RECRUITING

Columbus, Ohio, 43214, United States
Overlake Hospital Medical Center
RECRUITING

Bellevue, Washington, 98004, United States
Piedmont Hospital
RECRUITING

Atlanta, Georgia, 30309, United States
Prisma Health Richland Hospital
RECRUITING

Columbia, South Carolina, 29203, United States
Providence St. Vincent Medical Center
RECRUITING

Portland, Oregon, 97225, United States
Rhode Island Hospital
RECRUITING

Providence, Rhode Island, 02903, United States
Samsung Medical Center
RECRUITING

Seoul, 06351, South Korea
Scripps Memorial Hospital
RECRUITING

La Jolla, California, 92037, United States
South Denver Cardiology Associates, PC
RECRUITING

Littleton, Colorado, 80120, United States
St. Francis Hospital
RECRUITING

Roslyn, New York, 11576, United States
St. Luke's Hospital of Kansas City
RECRUITING

Kansas City, Missouri, 64111, United States
Stanford University Medical Center
RECRUITING

Stanford, California, 94305, United States
The Cardiac and Vascular Institute Research Foundation
RECRUITING

Gainesville, Florida, 32605, United States
The First Affiliated Hospital of Xi'an Jiaotong University
RECRUITING

Xi'an, 710061, China
The First Affiliated Hospital, Sun Yat-sen University
RECRUITING

Guangzhou, Guangzhou, 510080, China
The Heart Hospital Baylor Plano
RECRUITING

Plano, Texas, 75093, United States
The Methodist Hospital Research Institute
RECRUITING

Houston, Texas, 77030, United States
The Prince Charles Hospital
NOT_YET_RECRUITING

Chermside, Queensland, 4032, Australia
UPMC Pinnacle
RECRUITING

Mechanicsburg, Pennsylvania, 17050, United States
USC Medical Center
RECRUITING

Los Angeles, California, 90033, United States
University of California San Francisco
RECRUITING

San Francisco, California, 94143, United States
University of Michigan Hospitals
RECRUITING

Ann Arbor, Michigan, 48109, United States
University of Virginia Medical Center
RECRUITING

Charlottesville, Virginia, 22908, United States
Victorian Heart Hospital
NOT_YET_RECRUITING

Clayton, Victoria, 3168, Australia
Vital Heart and Vein
RECRUITING

Humble, Texas, 77338, United States
Wellstar Kennestone Hospital
RECRUITING

Marietta, Georgia, 30060, United States
Wuhan Asia Heart Hospital
RECRUITING

Wuhan, Hubei, 430022, China
York Hospital
RECRUITING

York, Pennsylvania, 17403, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.