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.
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.
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.
Parallel
Drug Eluting Balloon
DeviceAGENT DCB
Drug eluting stent
DeviceAny commercially available DES used for standard of care.
Plain old balloon angioplasty
Procedure/SurgeryBifurcation side branch - POBA
8
Treatment groupsSee each treatment group below.
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.
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