Coronary Artery Disease (CAD), Coronary Calcification, Coronary Calcified Disease, Coronary Calcified Nodules
Conditions
Keywords
Aero CAD, Aero IVL, IVL
Brief 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.
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.
Interventions
DEVICEShockwave C2 Aero Coronary IVL System
Participants undergoing PCI with coronary IVL using the Shockwave C2 Aero system followed by stent placement.
Sponsors
OPCI Core Laboratories LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Target Lesion Failure (TLF) | 30 days | Composite of cardiac death, target vessel myocardial infarction (TV-MI), or ischemia-driven target lesion revascularization (ID-TLR) |
| Procedural Success | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Device Success | Index procedure | Successful delivery, inflation, and activation of the IVL catheter at the target lesion without device-related complications |
| Serious Angiographic Complications | Index procedure | Occurrence of major procedural complications including coronary perforation, severe dissection (≥Type C), abrupt closure, or no-reflow |
| IVL Device Utilization | Index procedure | Number of IVL catheters used per case and need for adjunctive devices (e.g., atherectomy, specialty balloons, guide extension) |
| Target Lesion Failure (TLF) at 1 Year | 1 year | Composite of cardiac death, target vessel myocardial infarction, or ischemia-driven target lesion revascularization |
| Individual Components of TLF | 30 days and 1 year | Rates of cardiac death, target vessel MI, and ischemia-driven TLR analyzed separately |
| Stent Thrombosis | 30 days and 1 year | Definite or probable stent thrombosis based on ARC criteria |
| All-Cause Mortality | 30 days and 1 year | Death from any cause |
Countries
United States
Contacts
CONTACTFernando A Sosa, MBA
PRINCIPAL_INVESTIGATORAllen Jeremias, MD, MSc
St Francis Hospital & Heart Center
Outcome results
None listed