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

Launched by BOSTON SCIENTIFIC CORPORATION · May 5, 2025

Keywords

ClinConnect Summary

The AGENT DCB STANCE clinical trial is designed to evaluate a new treatment option for patients with coronary artery disease (CAD) who have a specific type of blockage called a de novo coronary lesion. This trial will compare the AGENT Drug-Coated Balloon, a new device used to open up blocked arteries, with the standard treatment, which typically involves inserting a drug-eluting stent or performing balloon angioplasty. The goal of the study is to determine how safe and effective the AGENT Drug-Coated Balloon is for treating these blockages.

To be eligible for the trial, participants must be at least 18 years old and have a specific type of blockage in their coronary arteries that needs treatment. They should be able to comply with study requirements and provide informed consent, meaning they understand what the trial involves. Participants will also be closely monitored after the procedure to ensure their safety and assess the treatment's effectiveness. It's important to note that several health conditions could exclude someone from participating, such as serious illnesses that could affect their life expectancy or recent heart issues. If you're interested or think you might qualify, it's best to discuss this with your healthcare provider.

Gender

ALL

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.