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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm - C2 Aero IVL | Other | Participants undergoing PCI with coronary IVL using the Shockwave C2 Aero system followed by stent placement. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Shockwave C2 Aero Coronary IVL System | Device | Participants undergoing PCI with coronary IVL using the Shockwave C2 Aero system followed by stent placement. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Target Lesion Failure (TLF) | Composite of cardiac death, target vessel myocardial infarction (TV-MI), or ischemia-driven target lesion revascularization (ID-TLR) | 30 days |
| Procedural Success | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Device Success | Successful delivery, inflation, and activation of the IVL catheter at the target lesion without device-related complications | Index procedure |
| Serious Angiographic Complications |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fernando A Sosa, MBA | Contact | 718-753-4862 | fernando.sosa@opci.live |
| Name | Affiliation | Role |
|---|---|---|
| Allen Jeremias, MD, MSc | St Francis Hospital & Heart Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Los Robles Regional Medical Center | Thousand Oaks | California | 91360 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39132214 | Background | Riley RF, Patel MP, Abbott JD, Bangalore S, Brilakis ES, Croce KJ, Doshi D, Kaul P, Kearney KE, Kerrigan JL, McEntegart M, Maehara A, Rymer JA, Sutton NR, Shah B. SCAI Expert Consensus Statement on the Management of Calcified Coronary Lesions. J Soc Cardiovasc Angiogr Interv. 2024 Jan 31;3(2):101259. doi: 10.1016/j.jscai.2023.101259. eCollection 2024 Feb. | |
| 30686041 |
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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.
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Occurrence of major procedural complications including coronary perforation, severe dissection (≥Type C), abrupt closure, or no-reflow
| Index procedure |
| IVL Device Utilization | 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 | Composite of cardiac death, target vessel myocardial infarction, or ischemia-driven target lesion revascularization | 1 year |
| Individual Components of TLF | Rates of cardiac death, target vessel MI, and ischemia-driven TLR analyzed separately | 30 days and 1 year |
| Stent Thrombosis | Definite or probable stent thrombosis based on ARC criteria | 30 days and 1 year |
| All-Cause Mortality | Death from any cause | 30 days and 1 year |
| Henry Ford St. John Hospital | Detroit | Michigan | 48236 | United States |
|
| Jersey Shore University Medical Center | Neptune City | New Jersey | 07753 | United States |
|
| The Valley Hospital | Paramus | New Jersey | 07652 | United States |
|
| St Francis Hospital & Heart Center | Roslyn | New York | 11576 | United States |
|
| Good Samaritan University Hospital | West Islip | New York | 11795 | United States |
|
| WellSpan Health, York Hospital | York | Pennsylvania | 17403 | United States |
|
| Baylor Scott & White Health - The Heart Hospital Plano | Plano | Texas | 75093 | United States |
|
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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