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).
The 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.
Age ≥18 years
Patient undergoing percutaneous coronary intervention (PCI) for coronary artery disease
Target lesion(s) intended for treatment with intravascular lithotripsy (IVL) and stent implantation per standard of care
Ability to provide informed consent
ST-elevation myocardial infarction (STEMI) at presentation
Cardiogenic shock at time of procedure
In-stent restenosis (ISR) target lesion
Known contraindication to antiplatelet or anticoagulation therapy
OPCI Core Laboratories LLC
Lead sponsor
St. Francis Hospital, New York
Sponsor institution