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MD",{"type":23,"investigatorFullName":173,"investigatorTitle":174,"investigatorAffiliation":175,"oldNameTitle":18,"oldOrganization":18},"Allen Jeremias","Director, Cardiac Catheterization Laboratory","St. Francis Hospital, New York","100632324","aero-cad-study-evaluating-the-shockwave-c2-aero-ivl-system-in-coronary-artery-disease-100632324",false,"NCT07512206","AERO CAD Study Evaluating the Shockwave C2 Aero IVL System in Coronary Artery Disease","AERO CAD: A Prospective, Multi-Center, Single-Arm Study Evaluating the Shockwave C2 Aero Coronary IVL System in Calcified Coronary Artery Disease","AERO CAD","Inclusion Criteria:\n\n1. Age ≥18 years\n2. Patient undergoing percutaneous coronary intervention (PCI) for coronary artery disease\n3. Target lesion(s) intended for treatment with intravascular lithotripsy (IVL) and stent implantation per standard of care\n4. Ability to provide informed consent\n5. Willingness and ability to comply with study follow-up requirements\n\nExclusion Criteria:\n\n1. ST-elevation myocardial infarction (STEMI) at presentation\n2. Cardiogenic shock at time of procedure\n3. In-stent restenosis (ISR) target lesion\n4. Known contraindication to antiplatelet or anticoagulation therapy\n5. Known intolerance or contraindication to contrast media not amenable to premedication\n6. Participation in another investigational drug or device study that could interfere with the endpoints of this study\n7. Life expectancy \\\u003C1 year\n8. Inability or unwillingness to comply with study procedures or follow-up","ALL","18 Years",{"count":187,"type":188},200,"ESTIMATED","INTERVENTIONAL",[191],"NA","The AERO CAD study is a prospective, multi-center, single-arm, post-market clinical investigation evaluating the procedural performance and clinical outcomes of the Shockwave C2 Aero Coronary Intravascular Lithotripsy (IVL) System in patients with calcified coronary artery disease undergoing percutaneous coronary intervention (PCI).\n\nThe study will enroll up to 200 subjects across up to 8 U.S. sites. The primary objective is to generate real-world evidence on device performance and clinical outcomes, including target lesion failure at 30 days and procedural success.",[194,195,196,197],"Coronary Artery Disease (CAD)","Coronary Calcification","Coronary Calcified Disease","Coronary Calcified Nodules",[199,200,201],"Aero CAD","Aero IVL","IVL","NOT_YET_RECRUITING","2026-04-01",{"date":205,"type":206},"2026-04-06","ACTUAL",{"date":203,"type":188},{"date":209,"type":188},"2026-12-01",{"name":5,"class":6},8]