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

May 6, 2026 updated by: Boston Scientific Corporation

AGENT DCB STANCE: AGENT Drug-Coated Balloon for STent AvoidANCE in PCI for De Novo Coronary Artery Disease

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The study will also contain a PK sub study and an IVUS sub study.

Study Type

Interventional

Enrollment (Estimated)

1616

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Australia
    • Queensland
      • Chermside, Queensland, Australia, 4032
    • Victoria
      • Clayton, Victoria, Australia, 3168
  • China
    • Beijin
      • Beijin, Beijin, China, 100000
        • Recruiting
        • Fuwai Hospital Chinese Academy of Medical Sciences
        • Contact:
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100000
        • Recruiting
        • Beijing Anzhen Hospital of the Capital University of Medical Sciences
        • Contact:
    • Guangzhou
      • Guangzhou, Guangzhou, China, 510080
        • Recruiting
        • The First Affiliated Hospital, Sun Yat-sen University
        • Contact:
    • Hubei
      • Wuhan, Hubei, China, 430022
        • Recruiting
        • Wuhan Asia Heart Hospital
        • Contact:
  • Germany
      • Cologne, Germany, 50733
  • Ireland
      • Dublin, Ireland, D07 RD8P
  • New Zealand
      • Auckland, New Zealand, 1010
        • Not yet recruiting
        • Auckland City Hospital
        • Contact:
  • Spain
      • Madrid, Spain, 28006
        • Recruiting
        • Hospital Universitario de La Princesa
        • Contact:
      • Valencia, Spain, 46026
        • Recruiting
        • Hospital Universitario y Politécnico La FE
        • Contact:
      • Valladolid, Spain, 47012
        • Recruiting
        • Clínico de Valladolid
        • Contact:
  • United States
    • California
      • La Jolla, California, United States, 92037
      • Los Angeles, California, United States, 90048
        • Recruiting
        • Cedars - Sinai Medical Center
        • Contact:
      • Los Angeles, California, United States, 90033
      • San Francisco, California, United States, 94143
        • Recruiting
        • University of California San Francisco
        • Contact:
      • Stanford, California, United States, 94305
        • Recruiting
        • Stanford University Medical Center
        • Contact:
    • Colorado
      • Littleton, Colorado, United States, 80120
        • Recruiting
        • South Denver Cardiology Associates, PC
        • Contact:
    • Florida
      • Gainesville, Florida, United States, 32605
        • Recruiting
        • The Cardiac and Vascular Institute Research Foundation
        • Contact:
    • Georgia
      • Atlanta, Georgia, United States, 30309
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Emory University Hospital
        • Contact:
      • Marietta, Georgia, United States, 30060
    • Illinois
      • Glenview, Illinois, United States, 60026
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Recruiting
        • Brigham and Women's Hospital
        • Contact:
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital
        • Contact:
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Beth Israel Deaconess Medical Center
        • Contact:
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • University of Michigan Hospitals
        • Contact:
      • Detroit, Michigan, United States, 48202
        • Recruiting
        • Henry Ford Hospital
        • Contact:
      • Grand Rapids, Michigan, United States, 49503
    • Minnesota
      • Coon Rapids, Minnesota, United States, 55433
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Recruiting
        • St. Luke's Hospital of Kansas City
        • Contact:
    • New York
      • New York, New York, United States, 10032
        • Recruiting
        • Columbia University Medical Center
        • Contact:
      • New York, New York, United States, 10029
      • Roslyn, New York, United States, 11576
        • Recruiting
        • St. Francis Hospital
        • Contact:
      • The Bronx, New York, United States, 10467
        • Recruiting
        • Montefiore Medical Center
        • Contact:
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
    • Ohio
      • Cincinnati, Ohio, United States, 45219
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic Foundation
        • Contact:
      • Columbus, Ohio, United States, 43214
        • Recruiting
        • Ohio Health Riverside Methodist Hospital
        • Contact:
    • Oregon
      • Portland, Oregon, United States, 97225
    • Pennsylvania
      • Mechanicsburg, Pennsylvania, United States, 17050
        • Recruiting
        • UPMC Pinnacle
        • Contact:
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Recruiting
        • Rhode Island Hospital
        • Contact:
    • South Carolina
      • Columbia, South Carolina, United States, 29203
    • Texas
      • Austin, Texas, United States, 78705
      • Dallas, Texas, United States, 75226
      • Houston, Texas, United States, 77030
        • Recruiting
        • The Methodist Hospital Research Institute
        • Contact:
      • Plano, Texas, United States, 75093
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • Methodist Healthcare System of San Antonio dba Methodist Hospital
        • Contact:
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • Recruiting
        • University of Virginia Medical Center
        • Contact:
    • West Virginia
      • Charleston, West Virginia, United States, 25304

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.).
  • 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%.
  • Subject had PCI or other coronary interventions within the last 30 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 NSTEMI 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).

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.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Small Vessel - Test
Small vessel subjects treated with AGENT DCB
Device: Drug Eluting Balloon
AGENT DCB
Other Names:
  • DCB
Active Comparator: Small Vessel - Control
Small vessel subjects treated with drug eluting stent
Device: Drug eluting stent
Any commercially available DES used for standard of care.
Other Names:
  • DES
Experimental: Bifurcation - Test
Bifurcation subjects with side branches treated with AGENT DCB
Device: Drug Eluting Balloon
AGENT DCB
Other Names:
  • DCB
Active Comparator: Bifurcation - Control
Bifurcation subjects with side branches treated with drug eluting stent or plain old balloon angioplasty
Device: Drug eluting stent
Any commercially available DES used for standard of care.
Other Names:
  • DES
Procedure: Plain old balloon angioplasty
Bifurcation side branch - POBA
Experimental: Long Lesion - Test
Long lesion subjects treated with AGENT DCB
Device: Drug Eluting Balloon
AGENT DCB
Other Names:
  • DCB
Active Comparator: Long Lesion - Control
Long lesion subjects treated with drug eluting stent
Device: Drug eluting stent
Any commercially available DES used for standard of care.
Other Names:
  • DES
Experimental: Overall - Test
All subjects treated with AGENT DCB
Device: Drug Eluting Balloon
AGENT DCB
Other Names:
  • DCB
Active Comparator: Overall - Control
All subjects treated with standard of care drug eluting stent and/or POBA
Device: Drug eluting stent
Any commercially available DES used for standard of care.
Other Names:
  • DES
Procedure: Plain old balloon angioplasty
Bifurcation side branch - POBA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Target Lesion Failure (TLF) rate
Time Frame: 12-Month
Target Lesion Failure (TLF) rate - defined as any ischemia-driven revascularization of the target lesion (TLR), myocardial infarction (MI, Q-wave and non-Q-wave) related to the target vessel, or cardiac death. The MI events include the Peri-Procedural MI (PPMI) according to the SCAI MI definition and the spontaneous MI according to the 4th Universal MI definition.
12-Month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Scientific Corporation

Investigators

  • Principal Investigator: David Kandzari, Piedmont Heart Institute
  • Principal Investigator: Margaret McEntegart, NYPH/CUIMC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 21, 2025

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

March 1, 2032

Study Registration Dates

First Submitted

April 28, 2025

First Submitted That Met QC Criteria

May 5, 2025

First Posted (Actual)

May 6, 2025

Study Record Updates

Last Update Posted (Actual)

May 7, 2026

Last Update Submitted That Met QC Criteria

May 6, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S2530

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

The data and study protocol for this clinical trial may be made available to other researchers in accordance with the Boston Scientific Data Sharing Policy (http://www.bostonscientific.com/en-US/data-sharing-requests.html)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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