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

Eligibility & Interventions

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 1,616 participants in total. It began in 2025-08-21 with a primary completion date of 2028-03.

Brief 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 balloon angioplasty in patients with de novo coronary lesions. Subjects must have a de novo target lesion located in a native coronary artery.

Eligibility 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.

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