Recruiting

AGENT DCB

Sponsor:

Boston Scientific Corporation

Code:

NCT06959524

Conditions

Coronary Arterial Disease (CAD)

de Novo Lesions in Native Coronary Arteries

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Drug Eluting Balloon

Drug eluting stent

Plain old balloon angioplasty

Study Details

Brief 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.

Conditions

Coronary Arterial Disease (CAD)

de Novo Lesions in Native Coronary Arteries

Study ID

NCT06959524

Start date

Aug 21, 2025

Status verified date

Aug, 2026

Completion date

Mar, 2032

Anticipated

Primary completion date

Mar, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

1616 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Small Vessel - Test

Small vessel subjects treated with AGENT DCB

active comparator: Small Vessel - Control

Small vessel subjects treated with drug eluting stent

experimental: Bifurcation - Test

Bifurcation subjects with side branches treated with AGENT DCB

active comparator: Bifurcation - Control

Bifurcation subjects with side branches treated with drug eluting stent or plain old balloon angioplasty

experimental: Long Lesion - Test

Long lesion subjects treated with AGENT DCB

active comparator: Long Lesion - Control

Long lesion subjects treated with drug eluting stent

experimental: Overall - Test

All subjects treated with AGENT DCB

active comparator: Overall - Control

All subjects treated with standard of care drug eluting stent and/or POBA

Interventions

Drug Eluting Balloon

AGENT DCB

Drug eluting stent

Any commercially available DES used for standard of care.

Plain old balloon angioplasty

Bifurcation side branch - POBA

Primary outcome measure

  • Target Lesion Failure (TLF) rate [ Time Frame: 12-Month ]

Central Contacts and Locations

Central contacts

Beth Lawson

508-683-6560beth.lawson@bsci.com

Kim Pena-Trast

904-314-4269kim.pena-trast@bsci.com

Locations

St. Bernard's Medical Center

Recruiting

Jonesboro, Arkansas, United States, 72401

Contacts

Maximiliano Arroyo, MD

870-207-3812maxarr@hotmail.com

Scripps Memorial Hospital

Recruiting

La Jolla, California, United States, 92037

Contacts

Matthew Price, MD

858-824-5222price.matthew@scrippshealth.org

USC Medical Center

Recruiting

Los Angeles, California, United States, 90033

Contacts

Jubin Joseph, MD

310-423-0106jubin.joseph@med.usc.edu

Cedars - Sinai Medical Center

Recruiting

Los Angeles, California, United States, 90048

Contacts

Suhail Dohad, MD

310-248-8245suhail.dohad@cshs.org

University of California San Francisco

Recruiting

San Francisco, California, United States, 94143

Contacts

Yousif Ahmad, MD

415-353-2341yousif.ahmad@ucsf.edu

Stanford University Medical Center

Recruiting

Stanford, California, United States, 94305

Contacts

Jennifer Tremmel, MD

650-704-4740jtremmel@stanford.edu

Los Robles Hospital & Medical Center

Recruiting

Thousand Oaks, California, United States, 91360

Contacts

Dhananjay Chatterjee, MD

805-796-3746dchatterjee@mednet.ucla.edu

South Denver Cardiology Associates, PC

Recruiting

Littleton, Colorado, United States, 80120

Contacts

Cinthia Tjan Bateman, MD

303-715-2210cinthiab@southdenver.com

The Cardiac and Vascular Institute Research Foundation

Recruiting

Gainesville, Florida, United States, 32605

Contacts

Matheen Khuddus, MD

352-375-1212Mkhuddus@tcavi.com

Mount Sinai Medical Center

Recruiting

Miami Beach, Florida, United States, 33140

Contacts

Nirat Beohar, MD

305-674-2162nirat.beohar@msmc.com

Piedmont Hospital

Recruiting

Atlanta, Georgia, United States, 30309

Contacts

David Kandzari, MD

404-985-3746david.kandzari@piedmont.org

Emory University Hospital

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

William Nicholson, MD

404-727-7040wjnicho@emory.edu

Wellstar Kennestone Hospital

Recruiting

Marietta, Georgia, United States, 30060

Contacts

Arthur Reitman, MD

770-424-6893arthur.reitman@wellstar.org

Northwestern University

Recruiting

Evanston, Illinois, United States, 60208

Contacts

Daniel Schimmel Jr., MD

312-926-2826dschimme@nm.org

Endeavor Health

Recruiting

Glenview, Illinois, United States, 60026

Contacts

Justin Levisay, MD

847-570-2250justin.levisay@endeavorhealth.org

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Suzanne Baron, MD

781-744-8460Sbaron@mgb.org

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Kevin Croce, MD

857-307-1991kcroce@bwh.harvard.edu

Beth Israel Deaconess Medical Center

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Robert Yeh, MD

617-667-7000ryeh@bidmc.harvard.edu

University of Michigan Hospitals

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Daniel Menees, MD

734-615-3878dmenees@med.umich.edu

Henry Ford Hospital

Recruiting

Detroit, Michigan, United States, 48202

Contacts

Asaad Nakhle, MD

313-916-7614anakhle2@hfhs.org

Corewell Health

Recruiting

Grand Rapids, Michigan, United States, 49503

Contacts

Ryan Madder, MD

616-391-8367ryan.madder@corewellhealth.org

Mercy Hospital

Recruiting

Coon Rapids, Minnesota, United States, 55433

Contacts

Matthew Whitbeck, MD

763-427-9980matthew.whitbeck@mhvi.com

St. Luke's Hospital of Kansas City

Recruiting

Kansas City, Missouri, United States, 64111

Contacts

J. Aaron Grantham, MD

816-931-1883jgrantham@saint-lukes.org

NYU Langone Hospital

Recruiting

Brooklyn, New York, United States, 11220

Contacts

Atul Sharma, MD

212-263-5656Atul.Sharma@nyulangone.org

Mount Sinai Medical Center

Recruiting

New York, New York, United States, 10029

Contacts

Samin Sharma, MD

212-241-4021samin.sharma@mountsinai.org

Columbia University Medical Center

Recruiting

New York, New York, United States, 10032

Contacts

David Brogno, MD

201-447-8453db34@cumc.columbia.edu

St. Francis Hospital

Recruiting

Roslyn, New York, United States, 11576

Contacts

Allen Jeremias, MD

516-562-6790Allen.Jeremias@chsli.org

Montefiore Medical Center

Recruiting

The Bronx, New York, United States, 10467

Contacts

Yumiko Kanei, MD

646-648-6125ykanei@montefiore.org

Carolinas Medical Center

Recruiting

Charlotte, North Carolina, United States, 28204

Contacts

Nyal Borges, MD

704-446-3942Nyal.borges@advocatehealth.org

Lindner Center for Research and Education at Christ Hospital

Recruiting

Cincinnati, Ohio, United States, 45219

Contacts

Steven Rudick, MD

513-585-1777steven.rudick@thechristhospital.com

Cleveland Clinic Foundation

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Amar Krishnaswamy, MD

216-636-2824krishna2@ccf.org

Ohio Health Riverside Methodist Hospital

Recruiting

Columbus, Ohio, United States, 43214

Contacts

Arash Arshi, MD

614-262-6772arash.arshi@ohiohealth.com

Providence St. Vincent Medical Center

Recruiting

Portland, Oregon, United States, 97225

Contacts

Jason Wollmuth, MD

503-216-2099jason.wollmuth@providence.org

UPMC Pinnacle

Recruiting

Mechanicsburg, Pennsylvania, United States, 17050

Contacts

Torrey Schmidt, MD

717-731-0101schmidttr@upmc.edu

York Hospital

Recruiting

York, Pennsylvania, United States, 17403

Contacts

Paul Tolerico, MD

717-851-2441ptolerico@wellspan.org

Rhode Island Hospital

Recruiting

Providence, Rhode Island, United States, 02903

Contacts

Jinnette Dawn Abbott, MD

401-444-9828jabbott@brownhealth.org

Prisma Health Richland Hospital

Recruiting

Columbia, South Carolina, United States, 29203

Contacts

Vince Vismara, MD

803-434-7984vince.vismara@prismahealth.org

Baylor Heart & Vascular Hospital

Recruiting

Dallas, Texas, United States, 75226

Contacts

Robert Stoler, MD

214-820-9903robert.stoler@bswhealth.org

The Methodist Hospital Research Institute

Recruiting

Houston, Texas, United States, 77030

Contacts

Alpesh Shah, MD

713-441-1100arshah@houstonmethodist.org

Vital Heart and Vein

Recruiting

Humble, Texas, United States, 77338

Contacts

Ricky Ganim, MD

281-572-0109rganim@vitalheartandvein.com

The Heart Hospital Baylor Plano

Recruiting

Plano, Texas, United States, 75093

Contacts

Srinivasa Potluri, MD

469-800-6300srinivasa.potluri@bswhealth.org

Methodist Healthcare System of San Antonio dba Methodist Hospital

Recruiting

San Antonio, Texas, United States, 78229

Contacts

Jorge Alvarez, MD

210-614-5400alvarezja@yahoo.com

University of Virginia Medical Center

Recruiting

Charlottesville, Virginia, United States, 22908

Contacts

Angela Taylor, MD

434-466-5413amt6b@virginia.edu

Inova Fairfax Hospital

Recruiting

Falls Church, Virginia, United States, 22042

Contacts

Lindsey Cilia, MD

571-472-0227lcilia@VirginiaHeart.com

Overlake Hospital Medical Center

Recruiting

Bellevue, Washington, United States, 98004

Contacts

Robert Riley, MD

425-899-5419robert.riley@overlakehospital.org

Charleston Area Medical Center

Recruiting

Charleston, West Virginia, United States, 25304

Contacts

Elie Gharib, MD

304-388-9945elie.gharib@vandaliahealth.org

More Information

Sponsor

Boston Scientific Corporation

Last update posted

Aug 27, 2026

Last verified

Aug, 2026

Keywords

  • Drug Coated Balloon
  • de novo
  • 97279374

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Boston Scientific Corporation on 2026-08-27.