NCT07512206Not yet recruiting
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
Source: ClinicalTrials.gov · Last updated 6 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- First submitted
- 23 Mar 2026
- Start date
- 1 Apr 2026
- Primary completion date
- 1 Oct 2026
- Lead sponsor
- OPCI Core Laboratories LLC
- Diseases
- Coronary artery disease
- NCT number
- NCT07512206
What you commit to
- Study type: Interventional
- Planned participants: 200
- From 1 Apr 2026 to the primary completion date, 1 Oct 2026
- 8 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Known contraindication to antiplatelet or anticoagulation therapy
- Participation in another investigational drug or device study that could interfere with the endpoints of this study
Other illness
- ST-elevation myocardial infarction (STEMI) at presentation
Other
- Cardiogenic shock at time of procedure
- In-stent restenosis (ISR) target lesion
- Known intolerance or contraindication to contrast media not amenable to premedication
- Life expectancy \<1 year
- Inability or unwillingness to comply with study procedures or follow-up
Who the study is looking for
- Age ≥18 years
- Patient undergoing percutaneous coronary intervention (PCI) for coronary artery disease
- Target lesion(s) intended for treatment with intravascular lithotripsy (IVL) and stent implantation per standard of care
- Ability to provide informed consent
- Willingness and ability to comply with study follow-up requirements
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (8)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Henry Ford St. John Hospital Coordinator of this site? Confirm its status | Detroit | United States | Unknown status |
| Jersey Shore University Medical Center Coordinator of this site? Confirm its status | Neptune City | United States | Unknown status |
| The Valley Hospital Coordinator of this site? Confirm its status | Paramus | United States | Unknown status |
| Baylor Scott & White Health - The Heart Hospital Plano Coordinator of this site? Confirm its status | Plano | United States | Unknown status |
| St. Francis Hospital & Heart Center Coordinator of this site? Confirm its status | Roslyn | United States | Unknown status |
| Los Robles Regional Medical Center Coordinator of this site? Confirm its status | Thousand Oaks | United States | Unknown status |
| Good Samaritan University Hospital Coordinator of this site? Confirm its status | West Islip | United States | Unknown status |
| WellSpan Health-York Hospital Coordinator of this site? Confirm its status | York | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.