RECRUITING Not applicable ClinicalTrials.gov

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

Sponsor: Boston Scientific Corporation • ClinicalTrials.gov ID: NCT06959524

Registry updated: 2026-10-20

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Description

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.

Interventions

Drug Eluting Balloon (Device)
AGENT DCB
Drug eluting stent (Device)
Any commercially available DES used for standard of care.
Plain old balloon angioplasty (Procedure)
Bifurcation side branch - POBA

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.

Conditions

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

Locations

Honor Health — Scottsdale, Arizona, United States
St. Bernard's Medical Center — Jonesboro, Arkansas, United States
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
Northwestern University — Evanston, Illinois, 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
Vital Heart and Vein — Humble, 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
Overlake Hospital Medical Center — Bellevue, Washington, United States
Charleston Area Medical Center — Charleston, West Virginia, United States
The Prince Charles Hospital — Chermside, Queensland, Australia
Monash Medical Centre — 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
Krankenhaus der Barmherzigen Brüder — Trier, 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
Kitasato University Hospital — Sagamihara, Kanagawa, Japan
Kyorin University Hospital — Mitaka, Tokyo, Japan
Chikamori Hospital — Kochi, Japan
Auckland City Hospital — Auckland, New Zealand
Asan Medical Center — Seoul, South Korea
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

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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