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AERO CAD Study Evaluating the Shockwave C2 Aero IVL System in Coronary Artery Disease
Sponsor: OPCI Core Laboratories LLC
Summary
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.
Official title: AERO CAD: A Prospective, Multi-Center, Single-Arm Study Evaluating the Shockwave C2 Aero Coronary IVL System in Calcified Coronary Artery Disease
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
200
Start Date
2026-04-01
Completion Date
2026-12-01
Last Updated
2026-04-06
Healthy Volunteers
No
Conditions
Interventions
Shockwave C2 Aero Coronary IVL System
Participants undergoing PCI with coronary IVL using the Shockwave C2 Aero system followed by stent placement.
Locations (8)
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