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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

Boston Scientific Corporation · NCT06959524

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Not applicable
Target enrollment
1616
US sites recruiting
47
Study start
August 21, 2025
Record last updated
October 20, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Drug Eluting Balloon; Drug eluting stent; Plain old balloon angioplasty

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

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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.

Recruiting US locations

  • Honor Health

    Scottsdale, AZ 85258

    Site contact: Taral Patel, MD · 615-373-7600 · taral.patel@hcahealthcare.com

  • St. Bernard's Medical Center

    Jonesboro, AR 72401

    Site contact: Maximiliano Arroyo, MD · 870-207-3812 · maxarr@hotmail.com

  • Scripps Memorial Hospital

    La Jolla, CA 92037

    Site contact: Matthew Price, MD · 858-824-5222 · price.matthew@scrippshealth.org

  • USC Medical Center

    Los Angeles, CA 90033

    Site contact: Jubin Joseph, MD · 310-423-0106 · jubin.joseph@med.usc.edu

  • Cedars - Sinai Medical Center

    Los Angeles, CA 90048

    Site contact: Suhail Dohad, MD · 310-248-8245 · suhail.dohad@cshs.org

  • University of California San Francisco

    San Francisco, CA 94143

    Site contact: Yousif Ahmad, MD · 415-353-2341 · yousif.ahmad@ucsf.edu

  • Stanford University Medical Center

    Stanford, CA 94305

    Site contact: Jennifer Tremmel, MD · 650-704-4740 · jtremmel@stanford.edu

  • Los Robles Hospital & Medical Center

    Thousand Oaks, CA 91360

    Site contact: Saibal Kar, MD · 805-778-1111 · Saibal.Kar@hcahealthcare.com

  • South Denver Cardiology Associates, PC

    Littleton, CO 80120

    Site contact: Cinthia Tjan Bateman, MD · 303-715-2210 · cinthiab@southdenver.com

  • The Cardiac and Vascular Institute Research Foundation

    Gainesville, FL 32605

    Site contact: Matheen Khuddus, MD · 352-375-1212 · Mkhuddus@tcavi.com

  • Mount Sinai Medical Center

    Miami Beach, FL 33140

    Site contact: Nirat Beohar, MD · 305-674-2162 · nirat.beohar@msmc.com

  • Piedmont Hospital

    Atlanta, GA 30309

    Site contact: David Kandzari, MD · 404-985-3746 · david.kandzari@piedmont.org

  • Emory University Hospital

    Atlanta, GA 30322

    Site contact: William Nicholson, MD · 404-727-7040 · wjnicho@emory.edu

  • Wellstar Kennestone Hospital

    Marietta, GA 30060

    Site contact: Arthur Reitman, MD · 770-424-6893 · arthur.reitman@wellstar.org

  • Northwestern University

    Evanston, IL 60208

    Site contact: Daniel Schimmel Jr., MD · 312-926-2826 · dschimme@nm.org

  • Endeavor Health

    Glenview, IL 60026

    Site contact: Justin Levisay, MD · 847-570-2250 · justin.levisay@endeavorhealth.org

  • Massachusetts General Hospital

    Boston, MA 02114

    Site contact: Suzanne Baron, MD · 781-744-8460 · Sbaron@mgb.org

  • Brigham and Women's Hospital

    Boston, MA 02115

    Site contact: Kevin Croce, MD · 857-307-1991 · kcroce@bwh.harvard.edu

  • Beth Israel Deaconess Medical Center

    Boston, MA 02215

    Site contact: Robert Yeh, MD · 617-667-7000 · ryeh@bidmc.harvard.edu

  • University of Michigan Hospitals

    Ann Arbor, MI 48109

    Site contact: Daniel Menees, MD · 734-615-3878 · dmenees@med.umich.edu

  • Henry Ford Hospital

    Detroit, MI 48202

    Site contact: Asaad Nakhle, MD · 313-916-7614 · anakhle2@hfhs.org

  • Corewell Health

    Grand Rapids, MI 49503

    Site contact: Ryan Madder, MD · 616-391-8367 · ryan.madder@corewellhealth.org

  • Mercy Hospital

    Coon Rapids, MN 55433

    Site contact: Matthew Whitbeck, MD · 763-427-9980 · matthew.whitbeck@mhvi.com

  • St. Luke's Hospital of Kansas City

    Kansas City, MO 64111

    Site contact: J. Aaron Grantham, MD · 816-931-1883 · jgrantham@saint-lukes.org

  • NYU Langone Hospital

    Brooklyn, NY 11220

    Site contact: Atul Sharma, MD · 212-263-5656 · Atul.Sharma@nyulangone.org

  • Mount Sinai Medical Center

    New York, NY 10029

    Site contact: Samin Sharma, MD · 212-241-4021 · samin.sharma@mountsinai.org

  • Columbia University Medical Center

    New York, NY 10032

    Site contact: David Brogno, MD · 201-447-8453 · db34@cumc.columbia.edu

  • St. Francis Hospital

    Roslyn, NY 11576

    Site contact: Allen Jeremias, MD · 516-562-6790 · Allen.Jeremias@chsli.org

  • Montefiore Medical Center

    The Bronx, NY 10467

    Site contact: Yumiko Kanei, MD · 646-648-6125 · ykanei@montefiore.org

  • Carolinas Medical Center

    Charlotte, NC 28204

    Site contact: Nyal Borges, MD · 704-446-3942 · Nyal.borges@advocatehealth.org

  • Lindner Center for Research and Education at Christ Hospital

    Cincinnati, OH 45219

    Site contact: Steven Rudick, MD · 513-585-1777 · steven.rudick@thechristhospital.com

  • Cleveland Clinic Foundation

    Cleveland, OH 44195

    Site contact: Amar Krishnaswamy, MD · 216-636-2824 · krishna2@ccf.org

  • Ohio Health Riverside Methodist Hospital

    Columbus, OH 43214

    Site contact: Arash Arshi, MD · 614-262-6772 · arash.arshi@ohiohealth.com

  • Providence St. Vincent Medical Center

    Portland, OR 97225

    Site contact: Jason Wollmuth, MD · 503-216-2099 · jason.wollmuth@providence.org

  • UPMC Pinnacle

    Mechanicsburg, PA 17050

    Site contact: Torrey Schmidt, MD · 717-731-0101 · schmidttr@upmc.edu

  • York Hospital

    York, PA 17403

    Site contact: Paul Tolerico, MD · 717-851-2441 · ptolerico@wellspan.org

  • Rhode Island Hospital

    Providence, RI 02903

    Site contact: Jinnette Dawn Abbott, MD · 401-444-9828 · jabbott@brownhealth.org

  • Prisma Health Richland Hospital

    Columbia, SC 29203

    Site contact: Vince Vismara, MD · 803-434-7984 · vince.vismara@prismahealth.org

  • Baylor Heart & Vascular Hospital

    Dallas, TX 75226

    Site contact: Robert Stoler, MD · 214-820-9903 · robert.stoler@bswhealth.org

  • The Methodist Hospital Research Institute

    Houston, TX 77030

    Site contact: Alpesh Shah, MD · 713-441-1100 · arshah@houstonmethodist.org

  • Vital Heart and Vein

    Humble, TX 77338

    Site contact: Ricky Ganim, MD · 281-572-0109 · rganim@vitalheartandvein.com

  • The Heart Hospital Baylor Plano

    Plano, TX 75093

    Site contact: Srinivasa Potluri, MD · 469-800-6300 · srinivasa.potluri@bswhealth.org

  • Methodist Healthcare System of San Antonio dba Methodist Hospital

    San Antonio, TX 78229

    Site contact: Jorge Alvarez, MD · 210-614-5400 · alvarezja@yahoo.com

  • University of Virginia Medical Center

    Charlottesville, VA 22908

    Site contact: Angela Taylor, MD · 434-466-5413 · amt6b@virginia.edu

  • Inova Fairfax Hospital

    Falls Church, VA 22042

    Site contact: Lindsey Cilia, MD · 571-472-0227 · lcilia@VirginiaHeart.com

  • Overlake Hospital Medical Center

    Bellevue, WA 98004

    Site contact: Robert Riley, MD · 425-899-5419 · robert.riley@overlakehospital.org

  • Charleston Area Medical Center

    Charleston, WV 25304

    Site contact: Elie Gharib, MD · 304-388-9945 · elie.gharib@vandaliahealth.org

Study contacts (from the official record)

  • Beth Lawson · 508-683-6560 · beth.lawson@bsci.com
  • Kim Pena-Trast · 904-314-4269 · kim.pena-trast@bsci.com
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AGENT DCB STANCE: Safety and Effectiveness Study of AGENT… (NCT06959524) | Bored Studies