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AGENT DCB STANCE: AGENT Drug-Coated Balloon for Coronary Artery Disease

This study is looking at the safety and effectiveness of the AGENT Drug-Coated Balloon (DCB) compared to standard treatments for coronary artery disease (CAD). CAD happens when arteries that supply blood to your heart become narrowed. The AGENT DCB is being compared to standard treatments like drug-eluting stents (DES) or plain old balloon angioplasty (POBA). Researchers want to see if the AGENT DCB is as good as or better than these standard treatments for new blockages in your heart arteries. The main goal is to measure how often a problem called Target Lesion Failure (TLF) occurs after 12 months. You may be able to join if you are at least 18 years old and are eligible for a procedure called percutaneous coronary intervention (PCI). The study plans to enroll 1616 people, but its current status is unclear.

Study design
This is an open-label, randomized study where participants will be assigned by chance to receive either the AGENT DCB or standard care. It plans to include 1616 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, Target Lesion Failure, will be measured at 12 months after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

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

Recruiting
NAAges 18+InterventionalTreatment
Boston Scientific Corporation
~1,616 participants
Updated 2026-08-27 on ClinicalTrials.gov
What's tested:Drug Eluting BalloonDrug eluting stentPlain old balloon angioplasty

At a glance

Recruiting sites
66 of 68 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Target Lesion Failure (TLF) rate
Measured over 12-Month

Conditions

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

Explore related trials

Coronary Artery Disease

Where it's being run

68 sites across 36 states
California6
Texas6
New York5
Georgia3
Massachusetts3
Michigan3
Ohio3
Germany3

Study leadership

  • David Kandzari · PRINCIPAL_INVESTIGATOR · Piedmont Heart Institute
  • Margaret McEntegart · PRINCIPAL_INVESTIGATOR · NYPH/CUIMC

Who to contact

Beth Lawson
[email protected]
508-683-6560
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.
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.

Exclusion

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.
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.

What this trial measures

  • Target Lesion Failure (TLF) rate12-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.