AERO CAD: A Prospective, Multi-Center, Single-Arm Study Evaluating the Shockwave C2 Aero Coronary IVL System in Calcified Coronary Artery Disease
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 8
- 主要终点
- Target Lesion Failure (TLF)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •ST-elevation myocardial infarction (STEMI) at presentation
- •Cardiogenic shock at time of procedure
- •In-stent restenosis (ISR) target lesion
- •Known contraindication to antiplatelet or anticoagulation therapy
- •Known intolerance or contraindication to contrast media not amenable to premedication
- •Participation in another investigational drug or device study that could interfere with the endpoints of this study
- •Life expectancy <1 year
- •Inability or unwillingness to comply with study procedures or follow-up
研究组 & 干预措施
Single Arm - C2 Aero IVL
Participants undergoing PCI with coronary IVL using the Shockwave C2 Aero system followed by stent placement.
干预措施: Shockwave C2 Aero Coronary IVL System (Device)
结局指标
主要结局
Target Lesion Failure (TLF)
时间窗: 30 days
Composite of cardiac death, target vessel myocardial infarction (TV-MI), or ischemia-driven target lesion revascularization (ID-TLR)
Procedural Success
时间窗: 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
次要结局
- Device Success(Index procedure)
- Serious Angiographic Complications(Index procedure)
- IVL Device Utilization(Index procedure)
- Target Lesion Failure (TLF) at 1 Year(1 year)
- Individual Components of TLF(30 days and 1 year)
- Stent Thrombosis(30 days and 1 year)
- All-Cause Mortality(30 days and 1 year)
研究者
Allen Jeremias
Director, Cardiac Catheterization Laboratory
St. Francis Hospital, New York