AERO CAD: A Prospective, Multi-Center, Single-Arm Study Evaluating the Shockwave C2 Aero Coronary IVL System in Calcified Coronary Artery Disease
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.
Description
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 coati…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Age ≥18 years 2. Patient undergoing percutaneous coronary intervention (PCI) for coronary artery disease 3. Target lesion(s) intended for treatment with intravascular lithotripsy (IVL) and stent implantation per standard of care 4. Ability to provide informed consent 5. Willingness and ability to comply with study follow-up requirements Exclusion Criteria: 1. ST-elevation myocardial infarction (STEMI) at presentation 2. Cardiogenic shock at time of procedure 3. In-stent restenosis (ISR) target lesion 4. Known contraindication to antiplatelet or anticoagulation therapy…
Interventions
- DeviceShockwave 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 CenterThousand Oaks, California
- Henry Ford St. John HospitalDetroit, Michigan
- Jersey Shore University Medical CenterNeptune City, New Jersey
- The Valley HospitalParamus, New Jersey
- St Francis Hospital & Heart CenterRoslyn, New York
- Good Samaritan University HospitalWest Islip, New York