Sound waves smash heart artery calcium in new trial

NCT ID NCT07512206

Not yet recruiting Disease control Sponsor: OPCI Core Laboratories LLC Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new device called the Shockwave C2 Aero, which uses sound waves to break up calcium deposits in heart arteries before placing a stent. About 200 people with coronary artery disease will be enrolled across 8 U.S. sites. The goal is to see if the device works safely and effectively in real-world settings.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: Shockwave C2 Aero Coronary Intravascular Lithotripsy (IVL) System (a device that uses sound waves to break up calcium in heart arteries)
What this could lead to: If successful, this device could offer a safer, more effective way to treat heavily calcified coronary arteries, potentially reducing complications and improving long-term heart health.
What could go wrong: This is a small, early-stage study (200 people) without a comparison group, so results may not apply to everyone. Risks include artery damage, heart attack, or the device failing to work as intended.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

coronary artery disorder coronary atherosclerosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

CORONARY ARTERY DISEASE (CAD) CORONARY CALCIFICATION CORONARY CALCIFIED DISEASE CORONARY CALCIFIED NODULES

Contacts and locations

Locations

Baylor Scott & White Health - The Heart Hospital Plano

Plano, Texas, 75093, United States
Good Samaritan University Hospital

West Islip, New York, 11795, United States
Henry Ford St. John Hospital

Detroit, Michigan, 48236, United States
Jersey Shore University Medical Center

Neptune City, New Jersey, 07753, United States
Los Robles Regional Medical Center

Thousand Oaks, California, 91360, United States
St Francis Hospital & Heart Center

Roslyn, New York, 11576, United States
The Valley Hospital

Paramus, New Jersey, 07652, United States
WellSpan Health, York Hospital

York, Pennsylvania, 17403, United States

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