NCT07512206

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

AERO CAD: A Prospective, Multi-Center, Single-Arm Study Evaluating the Shockwave C2 Aero Coronary IVL System in Calcified Coronary Artery Disease

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: OPCI Core Laboratories LLC · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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 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.

Conditions

• Coronary Artery Disease (CAD)
• Coronary Calcification
• Coronary Calcified Disease
• Coronary Calcified Nodules

Interventions

Type	Name	Description
DEVICE	Shockwave C2 Aero Coronary IVL System	Participants undergoing PCI with coronary IVL using the Shockwave C2 Aero system followed by stent placement.

Timeline

• Start date: 2026-04-01
• Primary completion: 2026-10-01
• Completion: 2026-12-01
• First posted: 2026-04-06
• Last updated: 2026-04-06

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated device study