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Could a balloon replace stents for clogged heart arteries?

NCT ID NCT06959524

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Aug 28, 2026 · Updated 6 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.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 1,616 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2025

Expected to finish

Mar 2032

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Clinical Inclusion Criteria: * Subject must be at least 18 years of age. * Subject (or legal guardian) understands the trial requirements and the treatment procedures and provides written informed consent before any trial-specific tests or procedures are performed. * Subject is eligible for percutaneous coronary intervention (PCI). * Subject is willing to comply with all protocol-required follow-up evaluation. * Women of child-bearing potential must agree to use a reliable method of contraception from the time of screening through 12 months after the index procedure. Angiographic Inclusion Criteria: * Target lesion is a de novo lesion located in a native coronary artery. * Target lesion must have visually estimated stenosis \> 50% and \< 100% in symptomatic subjects (\>70% and \<100% in asymptomatic subjects) prior to lesion pre-dilation. * Target lesion must be successfully pre-dilated. * If a non-target lesion is treated, it must be treated first and must be deemed a success. Clinical Exclusion Criteria: * Subject has other serious medical illness (e.g. cancer, congestive heart failure) that may reduce life expectancy to less than 12 months. * Subject has current problems with substance abuse (e.g. alcohol, cocaine, heroin, etc.) as assessed by Investigator. * Subject has planned procedure that may cause non-compliance with the protocol or confound data interpretation. * Subject is participating in another investigational drug or device clinical study that has not reached its primary endpoint. * Subject intends to participate in another investigational drug or device clinical study within 12 months after the index procedure. * Subject is a woman who is pregnant or nursing. A pregnancy test must be performed within 7 days prior to the index procedure, except for women who definitely do not have child-bearing potential. * Subject has left ventricular ejection fraction known to be \< 30% within the last 12 months. * Subject had PCI or other coronary interventions within the last 3 days. * Subject has planned PCI or CABG after the index procedure. * Subject had STEMI or QWMI \<72h prior to the index procedure. * Subject presents with ACS and rising biomarkers, or ongoing chest pain or is hemodynamically unstable. * Subject has cardiogenic shock (SBP \< 80 mmHg requiring inotropes, IABP or fluid support). * Subject has history (within 6 months prior to the index procedure) of New York Heart Association (NYHA) class III or IV heart failure. * Subject is considered not able to tolerate at least 30 seconds of coronary occlusion of the target lesion. * Subject has known allergy to paclitaxel or other components of the used medical devices. * Subject has known hypersensitivity or contraindication to contrast dye that in the opinion of the investigator cannot be adequately pre-medicated. * Subject has intolerance to antiplatelet drugs, anticoagulants required for procedure. * Subject has platelet count \< 100k/mm3 (risk of bleeding) or \> 700k/mm3. * Subject with renal insufficiency (creatinine ≥2.0 mg/dl) or failure (dialysis dependent). * Subject has previous or planned (within 30 days) TAVR. * Previous cardiac transplant. Angiographic Exclusion Criteria: * In-stent restenosis. * Target lesion is located within a saphenous vein or arterial graft. * Target lesion is a total occlusion or has evidence of thrombus present in the target vessel. * Target lesion is severely calcified by angiography or has \> 270° calcium arc on intravascular imaging or requires atherectomy or requires intravascular lithotripsy. * Subject has unprotected left main coronary artery disease (\>50% diameter stenosis) or three-vessel coronary disease requiring revascularization of all 3 vessels. * Subject with planned treatment of lesion involving aortic ostial location \<3 mm from aorta. * Target Lesion is in a previously jailed side branch.

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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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    67 sites in 9 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

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

  • Monash Medical Centre

    RECRUITING

    Clayton, Victoria, 3168, Australia

  • 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. Bernard's Medical Center

    RECRUITING

    Jonesboro, Arkansas, 72401, 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

  • 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

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