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

Starting soon · Not applicable

Conditions studied: Coronary Artery Disease (CAD), Coronary Calcification, Coronary Calcified Disease, Coronary Calcified Nodules

In brief

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.

Key facts

Study ID

NCT07512206

Run by

OPCI Core Laboratories LLC

People needed

200

Starts

2026-04-01

Expected to finish

2026-12-01

Last updated by the study team

2026-04-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Los Robles Regional Medical Center — Thousand Oaks, California, United States
• Henry Ford St. John Hospital — Detroit, Michigan, United States
• Jersey Shore University Medical Center — Neptune City, New Jersey, United States
• The Valley Hospital — Paramus, New Jersey, United States
• St Francis Hospital & Heart Center — Roslyn, New York, United States
• Good Samaritan University Hospital — West Islip, New York, United States
• WellSpan Health, York Hospital — York, Pennsylvania, United States
• Baylor Scott & White Health - The Heart Hospital Plano — Plano, Texas, United States

Full record on ClinicalTrials.gov

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