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

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

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.

the study will also contain a pk sub study and an ivus sub study.

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 \ 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 \ 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.

Keywords: drug coated balloon de novo