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
Single group
Shockwave C2 Aero Coronary IVL System
DeviceParticipants undergoing PCI with coronary IVL using the Shockwave C2 Aero system followed by stent placement.
Target Lesion Failure (TLF)
Composite of cardiac death, target vessel myocardial infarction (TV-MI), or ischemia-driven target lesion revascularization (ID-TLR)
Procedural Success
Successful delivery of the IVL catheter, delivery of lithotripsy therapy, stent placement with ≤30% residual stenosis, and no in-hospital target lesion failure
Device Success
Successful delivery, inflation, and activation of the IVL catheter at the target lesion without device-related complications
Serious Angiographic Complications
Occurrence of major procedural complications including coronary perforation, severe dissection (≥Type C), abrupt closure, or no-reflow
IVL Device Utilization
Number of IVL catheters used per case and need for adjunctive devices (e.g., atherectomy, specialty balloons, guide extension)
Target Lesion Failure (TLF) at 1 Year
Composite of cardiac death, target vessel myocardial infarction, or ischemia-driven target lesion revascularization
Click on the lead sponsor to view all of their trials.
OPCI Core Laboratories LLC
Lead sponsor
St. Francis Hospital, New York
Sponsor institution
This trial is not recruiting at the moment. You can still explore other options:
