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ClinicalTrials.gov ID

NCT07512206

Lead Sponsor

OPCI Core Laboratories LLCOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

200Estimated

Last Update Posted

Apr 6, 2026Actual

Start Date

Apr 1, 2026Estimated

Primary Completion Date

Oct 1, 2026Estimated

Completion Date

Dec 1, 2026Estimated

Official Title

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

Brief 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.

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

• Shockwave C2 Aero Coronary IVL System

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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
5. Known intolerance or contraindication to contrast media not amenable to premedication
6. Participation in another investigational drug or device study that could interfere with the endpoints of this study
7. Life expectancy <1 year
8. Inability or unwillingness to comply with study procedures or follow-up

Primary Purpose

Treatment

Allocation

N/A

Interventional Model

Single Group Assignment

Masking

None (Open Label)

Lead Sponsor

OPCI Core Laboratories LLCOTHER

SYoung3@valleyhealth.com201.389.0194