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