Clinical trialNCT07512206Not, yet, recruitingInterventional

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

SponsorOPCI Core Laboratories LLCEnrollment200Coronary Artery Disease (CAD)Coronary CalcificationCoronary Calcified DiseaseCoronary Calcified Nodules

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Allen Jeremias, MD, MSc
St Francis Hospital & Heart Center
Principal InvestigatorKOL profile →
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

8 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

Los Robles Regional Medical Center
Thousand Oaks, California, United States
Dhananjay Chatterjee, MD
Henry Ford St. John Hospital
Detroit, Michigan, United States
Amir Kaki, MD
Jersey Shore University Medical Center
Neptune City, New Jersey, United States
Daniel H Kiss, MD
the Valley Hospital
Paramus, New Jersey, United States
Raj Tayal, MD
St Francis Hospital & Heart Center
Roslyn, New York, United States
Allen Jeremias, MD, MSc →Evan S Shlofmitz, DORichard A Shlofmitz, MDZiad A Ali, MD DPhil
Good Samaritan University Hospital
West Islip, New York, United States
Wellspan Health, York Hospital
York, Pennsylvania, United States
Rhian E Davies, DO, MS
Baylor Scott & White Health - the Heart Hospital Plano
Plano, Texas, United States
Chadi Dib, MDKarim Al-Azizi, MD

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 1 Apr 2026
Primary completion: 1 Oct 2026
Completion: 1 Dec 2026
Last update posted: 6 Apr 2026
Registered enrollment: 200
Registry id: NCT07512206

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.