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AGENT drug-coated balloon versus standard PCI for de novo coronary lesions

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

NA · Boston Scientific Corporation · NCT06959524

This trial tests whether the AGENT drug-coated balloon is a safe and effective alternative to drug-eluting stents or standard balloon angioplasty for adults with new (de novo) coronary artery lesions undergoing PCI.

Quick facts

PhaseNA
Study typeInterventional
Enrollment1616 (estimated)
Ages18 Years and up
SexAll
SponsorBoston Scientific Corporation (industry)
Locations50 sites (La Jolla, California and 49 other locations)
Trial IDNCT06959524 on ClinicalTrials.gov

What this trial studies

This prospective, multicenter, open-label, randomized 1:1 study compares a treatment strategy using the AGENT drug-coated balloon (DCB) to standard percutaneous coronary intervention (PCI) with drug-eluting stents (DES) and/or balloon angioplasty in adults with de novo lesions in native coronary arteries. Subjects with a pre-dilatable target lesion that meets angiographic stenosis criteria will be randomized to AGENT DCB or standard of care. The protocol includes pharmacokinetic and intravascular ultrasound (IVUS) substudies and requires follow-up visits to monitor safety and effectiveness outcomes. Enrollment and procedures take place at selected centers in Southern California and include a 12-month contraception requirement for women of child-bearing potential.

Who should consider this trial

Good fit: Ideal candidates are adults eligible for PCI who have a de novo, pre-dilatable lesion in a native coronary artery meeting the protocol's stenosis criteria and who can consent and attend required follow-up.

Not a fit: Patients with in-stent restenosis, lesions that cannot be pre-dilated or clearly require a stent scaffold (for example complex bifurcations or heavy calcification), or those unable to undergo or follow up after PCI are unlikely to benefit.

Why it matters

Potential benefit: If successful, this approach could provide an effective PCI option that avoids leaving a permanent stent, potentially reducing long-term device-related complications and simplifying antiplatelet therapy.

How similar studies have performed: Previous studies have shown promising but mixed results for DCB in de novo coronary lesions, with stronger evidence for small-vessel disease and in-stent restenosis but less consistent outcomes compared with DES.

Eligibility criteria

Show full inclusion / exclusion 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.).
* 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.

Where this trial is running

La Jolla, California and 49 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Coronary Arterial Disease, de Novo Lesions in Native Coronary Arteries, Drug Coated Balloon, de novo, 97279374

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.