MedTrace Logo

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

NCT07512206 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2026-04-06

No results posted yet for this study

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.

Conditions

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

Interventions

DEVICE

Shockwave C2 Aero Coronary IVL System

Participants undergoing PCI with coronary IVL using the Shockwave C2 Aero system followed by stent placement.

Sponsors & Collaborators

  • OPCI Core Laboratories LLC

    lead OTHER

Principal Investigators

  • Allen Jeremias, MD, MSc · St Francis Hospital & Heart Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-01
Primary Completion
2026-10-01
Completion
2026-12-01
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07512206 on ClinicalTrials.gov