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

April 1, 2026 updated by: Allen Jeremias, OPCI Core Laboratories LLC

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Thousand Oaks, California, United States, 91360
        • Los Robles Regional Medical Center
        • Contact:
        • Principal Investigator:
          • Dhananjay Chatterjee, MD
    • Michigan
      • Detroit, Michigan, United States, 48236
        • Henry Ford St. John Hospital
        • Principal Investigator:
          • Amir Kaki, MD
        • Contact:
          • Renee L Bess, BS, RDCS, RVT, CCRP
          • Phone Number: 313.343.4811
          • Email: rbess1@hfhs.org
    • New Jersey
      • Neptune City, New Jersey, United States, 07753
        • Jersey Shore University Medical Center
        • Contact:
        • Principal Investigator:
          • Daniel H Kiss, MD
      • Paramus, New Jersey, United States, 07652
        • The Valley Hospital
        • Contact:
        • Principal Investigator:
          • Raj Tayal, MD
    • New York
      • Roslyn, New York, United States, 11576
        • St Francis Hospital & Heart Center
        • Contact:
        • Principal Investigator:
          • Evan S Shlofmitz, DO
        • Sub-Investigator:
          • Ziad A Ali, MD DPhil
        • Sub-Investigator:
          • Allen Jeremias, MD, MSc
        • Sub-Investigator:
          • Richard A Shlofmitz, MD
      • West Islip, New York, United States, 11795
        • Good Samaritan University Hospital
        • Contact:
    • Pennsylvania
      • York, Pennsylvania, United States, 17403
        • WellSpan Health, York Hospital
        • Contact:
        • Principal Investigator:
          • Rhian E Davies, DO, MS
    • Texas
      • Plano, Texas, United States, 75093
        • Baylor Scott & White Health - The Heart Hospital Plano
        • Sub-Investigator:
          • Karim Al-Azizi, MD
        • Principal Investigator:
          • Chadi Dib, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Single Arm - C2 Aero IVL
Participants undergoing PCI with coronary IVL using the Shockwave C2 Aero system followed by stent placement.
Device: Shockwave C2 Aero Coronary IVL System
Participants undergoing PCI with coronary IVL using the Shockwave C2 Aero system followed by stent placement.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Target Lesion Failure (TLF)
Time Frame: 30 days
Composite of cardiac death, target vessel myocardial infarction (TV-MI), or ischemia-driven target lesion revascularization (ID-TLR)
30 days
Procedural Success
Time Frame: During procedure / during hospitalization (up to 5 days)
Successful delivery of the IVL catheter, delivery of lithotripsy therapy, stent placement with ≤30% residual stenosis, and no in-hospital target lesion failure
During procedure / during hospitalization (up to 5 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Device Success
Time Frame: Index procedure
Successful delivery, inflation, and activation of the IVL catheter at the target lesion without device-related complications
Index procedure
Serious Angiographic Complications
Time Frame: Index procedure
Occurrence of major procedural complications including coronary perforation, severe dissection (≥Type C), abrupt closure, or no-reflow
Index procedure
IVL Device Utilization
Time Frame: Index procedure
Number of IVL catheters used per case and need for adjunctive devices (e.g., atherectomy, specialty balloons, guide extension)
Index procedure
Target Lesion Failure (TLF) at 1 Year
Time Frame: 1 year
Composite of cardiac death, target vessel myocardial infarction, or ischemia-driven target lesion revascularization
1 year
Individual Components of TLF
Time Frame: 30 days and 1 year
Rates of cardiac death, target vessel MI, and ischemia-driven TLR analyzed separately
30 days and 1 year
Stent Thrombosis
Time Frame: 30 days and 1 year
Definite or probable stent thrombosis based on ARC criteria
30 days and 1 year
All-Cause Mortality
Time Frame: 30 days and 1 year
Death from any cause
30 days and 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

OPCI Core Laboratories LLC

Investigators

  • Principal Investigator: Allen Jeremias, MD, MSc, St Francis Hospital & Heart Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

March 23, 2026

First Submitted That Met QC Criteria

April 1, 2026

First Posted (Actual)

April 6, 2026

Study Record Updates

Last Update Posted (Actual)

April 6, 2026

Last Update Submitted That Met QC Criteria

April 1, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OPCI-AERO-CAD-1.8-Rev D

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be publicly shared. De-identified data may be made available upon reasonable request and subject to applicable approvals and data use agreements.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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