AERO CAD Study Evaluating the Shockwave C2 Aero IVL System in Coronary Artery Disease

The AERO CAD study is designed to characterize real-world clinical performance and outcomes associated with the commercially available Shockwave C2 Aero Coronary IVL catheter.

Coronary artery calcification presents a major challenge during PCI, often leading to suboptimal stent expansion and adverse clinical outcomes. Intravascular lithotripsy (IVL) has emerged as a calcium modification technology that facilitates lesion preparation at low balloon pressures.

The C2 Aero IVL catheter represents a next-generation iteration with improved deliverability, lower profile, enhanced hydrophilic coating, and improved balloon durability. This study evaluates its use in routine clinical practice.

This is a prospective, single-arm, interventional post-market study enrolling patients undergoing PCI with IVL and stenting per standard of care. No additional procedures beyond standard clinical practice are required.

Subjects will be followed through discharge, 30 days, and 1 year.

Inclusion criteria

• 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
• Willingness and ability to comply with study follow-up requirements

Exclusion criteria

• 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
• Known intolerance or contraindication to contrast media not amenable to premedication
• Participation in another investigational drug or device study that could interfere with the endpoints of this study
• Life expectancy <1 year
• Inability or unwillingness to comply with study procedures or follow-up