NCT06959524From ClinicalTrials.govRecruiting

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

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

At a glance

Phase: Phase not stated
Study type: Interventional
Sponsor: Boston Scientific Corporation
Enrolment target: 1,616
Started: 21 August 2025
Main results due: March 2028
Study sites: 69
Registry updated: 29 September 2026

Can you take part?

Aged 18 years and over.
Open to any sex.
You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria

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.

What this study is about

In the sponsor’s own words, from the registry.

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.

Study sites(69)

St. Bernard's Medical Center
Jonesboro, Arkansas, United States
Recruiting
Scripps Memorial Hospital
La Jolla, California, United States
Recruiting
USC Medical Center
Los Angeles, California, United States
Recruiting
Cedars - Sinai Medical Center
Los Angeles, California, United States
Recruiting
University of California San Francisco
San Francisco, California, United States
Recruiting
Stanford University Medical Center
Stanford, California, United States
Recruiting
Los Robles Hospital & Medical Center
Thousand Oaks, California, United States
Recruiting
South Denver Cardiology Associates, PC
Littleton, Colorado, United States
Recruiting
The Cardiac and Vascular Institute Research Foundation
Gainesville, Florida, United States
Recruiting
Mount Sinai Medical Center
Miami Beach, Florida, United States
Recruiting
Piedmont Hospital
Atlanta, Georgia, United States
Recruiting
Emory University Hospital
Atlanta, Georgia, United States
Recruiting
Wellstar Kennestone Hospital
Marietta, Georgia, United States
Recruiting
Northwestern University
Evanston, Illinois, United States
Recruiting
Endeavor Health
Glenview, Illinois, United States
Recruiting
Massachusetts General Hospital
Boston, Massachusetts, United States
Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, United States
Recruiting
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Recruiting
University of Michigan Hospitals
Ann Arbor, Michigan, United States
Recruiting
Henry Ford Hospital
Detroit, Michigan, United States
Recruiting
Corewell Health
Grand Rapids, Michigan, United States
Recruiting
Mercy Hospital
Coon Rapids, Minnesota, United States
Recruiting
St. Luke's Hospital of Kansas City
Kansas City, Missouri, United States
Recruiting
NYU Langone Hospital
Brooklyn, New York, United States
Recruiting
Mount Sinai Medical Center
New York, New York, United States
Recruiting
Columbia University Medical Center
New York, New York, United States
Recruiting
St. Francis Hospital
Roslyn, New York, United States
Recruiting
Montefiore Medical Center
The Bronx, New York, United States
Recruiting
Carolinas Medical Center
Charlotte, North Carolina, United States
Recruiting
Lindner Center for Research and Education at Christ Hospital
Cincinnati, Ohio, United States
Recruiting
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Recruiting
Ohio Health Riverside Methodist Hospital
Columbus, Ohio, United States
Recruiting
Providence St. Vincent Medical Center
Portland, Oregon, United States
Recruiting
UPMC Pinnacle
Mechanicsburg, Pennsylvania, United States
Recruiting
York Hospital
York, Pennsylvania, United States
Recruiting
Rhode Island Hospital
Providence, Rhode Island, United States
Recruiting
Prisma Health Richland Hospital
Columbia, South Carolina, United States
Recruiting
Heart Hospital of Austin
Austin, Texas, United States
Withdrawn
Baylor Heart & Vascular Hospital
Dallas, Texas, United States
Recruiting
The Methodist Hospital Research Institute
Houston, Texas, United States
Recruiting
Vital Heart and Vein
Humble, Texas, United States
Recruiting
The Heart Hospital Baylor Plano
Plano, Texas, United States
Recruiting
Methodist Healthcare System of San Antonio dba Methodist Hospital
San Antonio, Texas, United States
Recruiting
University of Virginia Medical Center
Charlottesville, Virginia, United States
Recruiting
Inova Fairfax Hospital
Falls Church, Virginia, United States
Recruiting
Overlake Hospital Medical Center
Bellevue, Washington, United States
Recruiting
Charleston Area Medical Center
Charleston, West Virginia, United States
Recruiting
The Prince Charles Hospital
Chermside, Queensland, Australia
Not yet recruiting
Monash Medical Centre
Clayton, Victoria, Australia
Recruiting
Beijing Anzhen Hospital of the Capital University of Medical Sciences
Beijing, Beijing Municipality, China
Recruiting
Fuwai Hospital Chinese Academy of Medical Sciences
Beijin, Beijin, China
Recruiting
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangzhou, China
Recruiting
Wuhan Asia Heart Hospital
Wuhan, Hubei, China
Recruiting
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, China
Recruiting
Cellitinnen Krankenhaus St. Vinzenz
Cologne, Germany
Recruiting
MEDICLIN Herzzentrum Lahr
Lahr, Germany
Withdrawn
Krankenhaus der Barmherzigen Brüder
Trier, Germany
Recruiting
Mater Private Hospital Cork
Cork, Ireland
Recruiting
Mater Private Hospital
Dublin, Ireland
Recruiting
Galway University Hospital
Galway, Ireland
Recruiting

Showing 60 of 69 sites — filter to narrow it down. 66 of the 69 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT06959524. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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