Coronary Arterial Disease (CAD)NCT06959524

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

A study testing Drug Eluting Balloon, Drug eluting stent and Plain old balloon angioplasty in people with Coronary Arterial Disease (CAD) and de Novo Lesions in Native Coronary Arteries, run by Boston Scientific Corporation at 71 sites in 9 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Coronary Arterial Disease (CAD), de Novo Lesions in Native Coronary Arteries
What is being tested?: Drug Eluting Balloon, Drug eluting stent and Plain old balloon angioplasty
Type of treatment: Medical device, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,616 participants
Where: 71 sitesin 9 countries
Study dates: 21 Aug 2025to Mar 2032
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

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.

Trial locations and contacts

71 sites in 9 countries. Contact the study team or a site near you to ask about taking part.

Beth Lawson contact

508-683-6560

beth.lawson@bsci.com

Kim Pena-Trast contact

904-314-4269

kim.pena-trast@bsci.com

Country

City, postcode or hospital

Sites recruiting now only

71 sites in 9 countries

United States48 sites, 47 recruiting

University of Michigan Hospitals
Ann Arbor, Michigan, 48109
Daniel Menees, MD, 734-615-3878, dmenees@med.umich.edu
Recruiting
Piedmont Hospital
Atlanta, Georgia, 30309
David Kandzari, MD, 404-985-3746, david.kandzari@piedmont.org
Recruiting
Emory University Hospital
Atlanta, Georgia, 30322
William Nicholson, MD, 404-727-7040, wjnicho@emory.edu
Recruiting
Heart Hospital of Austin
Austin, Texas, 78705
Withdrawn
Overlake Hospital Medical Center
Bellevue, Washington, 98004
Robert Riley, MD, 425-899-5419, robert.riley@overlakehospital.org
Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Suzanne Baron, MD, 781-744-8460, Sbaron@mgb.org
Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Kevin Croce, MD, 857-307-1991, kcroce@bwh.harvard.edu
Recruiting
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Robert Yeh, MD, 617-667-7000, ryeh@bidmc.harvard.edu
Recruiting
NYU Langone Hospital
Brooklyn, New York, 11220
Atul Sharma, MD, 212-263-5656, Atul.Sharma@nyulangone.org
Recruiting
Charleston Area Medical Center
Charleston, West Virginia, 25304
Elie Gharib, MD, 304-388-9945, elie.gharib@vandaliahealth.org
Recruiting
Carolinas Medical Center
Charlotte, North Carolina, 28204
Nyal Borges, MD, 704-446-3942, Nyal.borges@advocatehealth.org
Recruiting
University of Virginia Medical Center
Charlottesville, Virginia, 22908
Angela Taylor, MD, 434-466-5413, amt6b@virginia.edu
Recruiting
Lindner Center for Research and Education at Christ Hospital
Cincinnati, Ohio, 45219
Steven Rudick, MD, 513-585-1777, steven.rudick@thechristhospital.com
Recruiting
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Amar Krishnaswamy, MD, 216-636-2824, krishna2@ccf.org
Recruiting
Prisma Health Richland Hospital
Columbia, South Carolina, 29203
Vince Vismara, MD, 803-434-7984, vince.vismara@prismahealth.org
Recruiting
Ohio Health Riverside Methodist Hospital
Columbus, Ohio, 43214
Arash Arshi, MD, 614-262-6772, arash.arshi@ohiohealth.com
Recruiting
Mercy Hospital
Coon Rapids, Minnesota, 55433
Matthew Whitbeck, MD, 763-427-9980, matthew.whitbeck@mhvi.com
Recruiting
Baylor Heart & Vascular Hospital
Dallas, Texas, 75226
Robert Stoler, MD, 214-820-9903, robert.stoler@bswhealth.org
Recruiting
Henry Ford Hospital
Detroit, Michigan, 48202
Asaad Nakhle, MD, 313-916-7614, anakhle2@hfhs.org
Recruiting
Northwestern University
Evanston, Illinois, 60208
Daniel Schimmel Jr., MD, 312-926-2826, dschimme@nm.org
Recruiting
Inova Fairfax Hospital
Falls Church, Virginia, 22042
Lindsey Cilia, MD, 571-472-0227, lcilia@VirginiaHeart.com
Recruiting
The Cardiac and Vascular Institute Research Foundation
Gainesville, Florida, 32605
Matheen Khuddus, MD, 352-375-1212, Mkhuddus@tcavi.com
Recruiting
Endeavor Health
Glenview, Illinois, 60026
Justin Levisay, MD, 847-570-2250, justin.levisay@endeavorhealth.org
Recruiting
Corewell Health
Grand Rapids, Michigan, 49503
Ryan Madder, MD, 616-391-8367, ryan.madder@corewellhealth.org
Recruiting
The Methodist Hospital Research Institute
Houston, Texas, 77030
Alpesh Shah, MD, 713-441-1100, arshah@houstonmethodist.org
Recruiting
Vital Heart and Vein
Humble, Texas, 77338
Ricky Ganim, MD, 281-572-0109, rganim@vitalheartandvein.com
Recruiting
St. Bernard's Medical Center
Jonesboro, Arkansas, 72401
Maximiliano Arroyo, MD, 870-207-3812, maxarr@hotmail.com
Recruiting
St. Luke's Hospital of Kansas City
Kansas City, Missouri, 64111
J. Aaron Grantham, MD, 816-931-1883, jgrantham@saint-lukes.org
Recruiting
Scripps Memorial Hospital
La Jolla, California, 92037
Matthew Price, MD, 858-824-5222, price.matthew@scrippshealth.org
Recruiting
South Denver Cardiology Associates, PC
Littleton, Colorado, 80120
Cinthia Tjan Bateman, MD, 303-715-2210, cinthiab@southdenver.com
Recruiting
USC Medical Center
Los Angeles, California, 90033
Jubin Joseph, MD, 310-423-0106, jubin.joseph@med.usc.edu
Recruiting
Cedars - Sinai Medical Center
Los Angeles, California, 90048
Suhail Dohad, MD, 310-248-8245, suhail.dohad@cshs.org
Recruiting
Wellstar Kennestone Hospital
Marietta, Georgia, 30060
Arthur Reitman, MD, 770-424-6893, arthur.reitman@wellstar.org
Recruiting
UPMC Pinnacle
Mechanicsburg, Pennsylvania, 17050
Torrey Schmidt, MD, 717-731-0101, schmidttr@upmc.edu
Recruiting
Mount Sinai Medical Center
Miami Beach, Florida, 33140
Nirat Beohar, MD, 305-674-2162, nirat.beohar@msmc.com
Recruiting
Mount Sinai Medical Center
New York, New York, 10029
Samin Sharma, MD, 212-241-4021, samin.sharma@mountsinai.org
Recruiting
Columbia University Medical Center
New York, New York, 10032
David Brogno, MD, 201-447-8453, db34@cumc.columbia.edu
Recruiting
The Heart Hospital Baylor Plano
Plano, Texas, 75093
Srinivasa Potluri, MD, 469-800-6300, srinivasa.potluri@bswhealth.org
Recruiting
Providence St. Vincent Medical Center
Portland, Oregon, 97225
Jason Wollmuth, MD, 503-216-2099, jason.wollmuth@providence.org
Recruiting
Rhode Island Hospital
Providence, Rhode Island, 02903
Jinnette Dawn Abbott, MD, 401-444-9828, jabbott@brownhealth.org
Recruiting
St. Francis Hospital
Roslyn, New York, 11576
Allen Jeremias, MD, 516-562-6790, Allen.Jeremias@chsli.org
Recruiting
Methodist Healthcare System of San Antonio dba Methodist Hospital
San Antonio, Texas, 78229
Jorge Alvarez, MD, 210-614-5400, alvarezja@yahoo.com
Recruiting
University of California San Francisco
San Francisco, California, 94143
Yousif Ahmad, MD, 415-353-2341, yousif.ahmad@ucsf.edu
Recruiting
Honor Health
Scottsdale, Arizona, 85258
Taral Patel, MD, 615-373-7600, taral.patel@hcahealthcare.com
Recruiting
Stanford University Medical Center
Stanford, California, 94305
Jennifer Tremmel, MD, 650-704-4740, jtremmel@stanford.edu
Recruiting
Montefiore Medical Center
The Bronx, New York, 10467
Yumiko Kanei, MD, 646-648-6125, ykanei@montefiore.org
Recruiting
Los Robles Hospital & Medical Center
Thousand Oaks, California, 91360
Saibal Kar, MD, 805-778-1111, Saibal.Kar@hcahealthcare.com
Recruiting
York Hospital
York, Pennsylvania, 17403
Paul Tolerico, MD, 717-851-2441, ptolerico@wellspan.org
Recruiting

Other trials in United States

China5 sites, 5 recruiting

Fuwai Hospital Chinese Academy of Medical Sciences
Beijin, Beijin, 100000
Yongjian Wu, MD, 010-88398395, fwjg@fuwai.com
Recruiting
Beijing Anzhen Hospital of the Capital University of Medical Sciences
Beijing, Beijing Municipality, 100000
Yong Zeng, MD, 010-64456966, office@anzhengcp.com
Recruiting
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangzhou, 510080
Yi Li, MD, 020-87755766, zsyyyb@mail.sysu.edu.cn
Recruiting
Wuhan Asia Heart Hospital
Wuhan, Hubei, 430022
Dan Song, MD, 18963980171, Songdan8300@163.com
Recruiting
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, 710061
Zuyi Yuan, MD, 1 399 122 9101, nguomd@mail.xjtu.edu.cn
Recruiting

Other trials in China

Japan4 sites, 4 recruiting

Chikamori Hospital
Kochi, 780-8522
Ryuichiro Imai, MD, +81-88-822-5231, ryuichirou-imai@hkg.odn.ne.jp
Recruiting
Kyorin University Hospital
Mitaka, Tokyo, 181-8611
Kohei Koyama, MD, +81-422-47-5511, kkouhey21@ks.kyorin-u.ac.jp
Recruiting
Kitasato University Hospital
Sagamihara, Kanagawa, 252-0373
Junya Ako, MD, +81-42-778-8111, jako@kitasato-u.ac.jp
Recruiting
Medical Corporation Sapporo Heart Center Sapporo Cardiovascular Clinic
Sapporo, Hokkaido, 007-0849
Shoichi Kuramitsu, MD, +81-011-784-784-7, kuramitsu@heart-kizuna.com
Recruiting

Other trials in Japan

Germany3 sites, 2 recruiting

Cellitinnen Krankenhaus St. Vinzenz
Cologne, 50733
Jan-Malte Sinning, MD, +4922177120, jan-malte.sinning@cellitinnen.de
Recruiting
MEDICLIN Herzzentrum Lahr
Lahr, 77933
Withdrawn
Krankenhaus der Barmherzigen Brüder
Trier, 54292
Nikos Werner, MD, +496512081780, n.werner@bbtgruppe.de
Recruiting

Other trials in Germany

Ireland3 sites, 3 recruiting

Mater Private Hospital Cork
Cork, T12 K199
Paul Hill, MD, 0216013200, Paul.Hill@materprivate.ie
Recruiting
Mater Private Hospital
Dublin, D07 RD8P
Robert Byrne, MD, +353(0)12481843, Robert.byrne@materprivate.ie
Recruiting
Galway University Hospital
Galway, H91 YR71
Faisal Sharif, MD, 0861455568, Faisal.sharif@universityofgalway.ie
Recruiting

Other trials in Ireland

Spain3 sites, 3 recruiting

Hospital Universitario de La Princesa
Madrid, 28006
Fernando Alfonso, MD, +34913303283, falf@hotmail.com
Recruiting
Hospital Universitario y Politécnico La Fe
Valencia, 46026
Jorge Sanz, MD, +34961244000, sjorge4@gmx.com
Recruiting
Clínico de Valladolid
Valladolid, 47012
Ignacio Amat-Santos, MD, +34657923040, ijamat@gmail.com
Recruiting

Other trials in Spain

Australia2 sites, 2 recruiting

The Prince Charles Hospital
Chermside, Queensland, 4032
Rustem Dautov, MD, 0731394711, Rustem.Dautov@health.qld.gov.au
Recruiting
Monash Medical Centre
Clayton, Victoria, 3168
Robert Gooley, MD, +61 395 944 543, robert.gooley@monashhealth.org
Recruiting

Other trials in Australia

South Korea2 sites, 2 recruiting

Asan Medical Center
Seoul, 05505
Jung-Min Ahn, MD, 02230105904, drjmahn@cvrf.org
Recruiting
Samsung Medical Center
Seoul, 06351
Joo Myung Lee, MD, +82-2-3410-2575, drone80@hanmail.net
Recruiting

Other trials in South Korea

New Zealand1 site, 1 recruiting

Auckland City Hospital
Auckland, 1010
Jithendra Somaratne, MD, 6493074949, jithendras@adhb.govt.nz
Recruiting

Other trials in New Zealand

About this study

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

Subjects must have a de novo target lesion located in a native coronary artery.

Read the detailed description

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

Conditions: Coronary Arterial Disease (CAD), de Novo Lesions in Native Coronary Arteries
Being tested: Drug Eluting Balloon, Drug eluting stent, Plain old balloon angioplasty
Keywords: Drug Coated Balloon, de novo, 97279374

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Drug Eluting BalloonDevice
Also called DCB
AGENT DCB
Drug eluting stentDevice
Also called DES
Any commercially available DES used for standard of care.
Plain old balloon angioplastyProcedure or surgery
Bifurcation side branch - POBA

Study groups in NCT06959524
Study group	Role	What they receive
Small Vessel - Test	Experimental	Small vessel subjects treated with AGENT DCB Receives: Device: Drug Eluting Balloon
Small Vessel - Control	Active comparator	Small vessel subjects treated with drug eluting stent Receives: Device: Drug eluting stent
Bifurcation - Test	Experimental	Bifurcation subjects with side branches treated with AGENT DCB Receives: Device: Drug Eluting Balloon
Bifurcation - Control	Active comparator	Bifurcation subjects with side branches treated with drug eluting stent or plain old balloon angioplasty Receives: Device: Drug eluting stent; Procedure: Plain old balloon angioplasty
Long Lesion - Test	Experimental	Long lesion subjects treated with AGENT DCB Receives: Device: Drug Eluting Balloon
Long Lesion - Control	Active comparator	Long lesion subjects treated with drug eluting stent Receives: Device: Drug eluting stent
Overall - Test	Experimental	All subjects treated with AGENT DCB Receives: Device: Drug Eluting Balloon
Overall - Control	Active comparator	All subjects treated with standard of care drug eluting stent and/or POBA Receives: Device: Drug eluting stent; Procedure: Plain old balloon angioplasty

What is being measured

The primary outcome is the main question the study is designed to answer.

Target Lesion Failure (TLF) rate
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.
Measured: 12-Month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Aug 2025Mar 2032

First posted6 May 2025
Study start21 Aug 2025
Primary completionMar 2028 (estimated)
Study completionMar 2032 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Coronary Arterial Disease (CAD)Studies of the same condition, open and under way.
More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 1,616 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06959524
Sponsor's protocol ID: S2530
Status last verified: Oct 2026
First submitted: 28 Apr 2025
Last updated: 20 Oct 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: Undecided: 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)

Interested in taking part?

Beth Lawson

508-683-6560

beth.lawson@bsci.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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The OCTOBER Trial - European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction (OCTOBER)
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Thiamine Intervention and Coronary Artery Bypass Grafting
Coronary Heart Disease, Coronary Artery Bypass Grafting
Not yet recruitingObservational study
Preoperative Gastric Ultrasound and Anaesthetic Management in Patients Undergoing Coronary Artery Bypass Grafting
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All Coronary Arterial Disease (CAD) trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: AGENT DCB STANCE: AGENT Drug-Coated Balloon for STent AvoidANCE in PCI for De Novo Coronary Artery Disease
ClinicalTrials.gov ID: NCT06959524
Acronym / sponsor ID: S2530
Conditions: Coronary Arterial Disease (CAD), de Novo Lesions in Native Coronary Arteries
Keywords: Drug Coated Balloon, de novo, 97279374
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 1,616 participants (estimated)
Lead sponsor: Boston Scientific CorporationIndustry (pharma, biotech, devices)
Study start: 21 Aug 2025 (actual)
Primary completion: Mar 2028 (estimated)
Study completion: Mar 2032 (estimated)
First posted: 6 May 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Subjects must have a de novo target lesion located in a native coronary artery.

Detailed description

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 8

Arm	Type	Receives
Small Vessel - Test	Experimental	Device: Drug Eluting BalloonSmall vessel subjects treated with AGENT DCB
Small Vessel - Control	Active comparator	Device: Drug eluting stentSmall vessel subjects treated with drug eluting stent
Bifurcation - Test	Experimental	Device: Drug Eluting BalloonBifurcation subjects with side branches treated with AGENT DCB
Bifurcation - Control	Active comparator	Device: Drug eluting stent, Procedure: Plain old balloon angioplastyBifurcation subjects with side branches treated with drug eluting stent or plain old balloon angioplasty
Long Lesion - Test	Experimental	Device: Drug Eluting BalloonLong lesion subjects treated with AGENT DCB
Long Lesion - Control	Active comparator	Device: Drug eluting stentLong lesion subjects treated with drug eluting stent
Overall - Test	Experimental	Device: Drug Eluting BalloonAll subjects treated with AGENT DCB
Overall - Control	Active comparator	Device: Drug eluting stent, Procedure: Plain old balloon angioplastyAll subjects treated with standard of care drug eluting stent and/or POBA

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Drug Eluting BalloonAlso: DCBAGENT DCB	Device	Bifurcation - Test, Long Lesion - Test, Overall - Test, Small Vessel - Test
Drug eluting stentAlso: DESAny commercially available DES used for standard of care.	Device	Bifurcation - Control, Long Lesion - Control, Overall - Control, Small Vessel - Control
Plain old balloon angioplastyBifurcation side branch - POBA	Procedure or surgery	Bifurcation - Control, Overall - Control

Primary outcome

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.

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
Individual participant dataSharing planned: Undecided. 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)

Related trials for Coronary Arterial Disease (CAD)

Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
Active, not recruiting
The OCTOBER Trial - European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction (OCTOBER)
Ischaemic Heart Disease, Ischemic Heart Disease
RecruitingEarly Phase 1
Thiamine Intervention and Coronary Artery Bypass Grafting
Coronary Heart Disease, Coronary Artery Bypass Grafting
Not yet recruitingObservational study
Preoperative Gastric Ultrasound and Anaesthetic Management in Patients Undergoing Coronary Artery Bypass Grafting
Preoperative Fasting, Pulmonary Aspiration During Anesthetic Induction

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Beth Lawson contact

508-683-6560

beth.lawson@bsci.com

Kim Pena-Trast contact

904-314-4269

kim.pena-trast@bsci.com

David Kandzari principal investigator

Piedmont Heart Institute

Margaret McEntegart principal investigator

NYPH/CUIMC

71 sites in 9 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 71 sites in United States, China, Japan, Germany, Ireland and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Beth Lawson (508-683-6560, beth.lawson@bsci.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Target Lesion Failure (TLF) rate (time frame: 12-Month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06959524.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.