New Enrollment Post Approval Registry for the Shockwave Intravascular Lithotripsy (IVL) System With Shockwave C2 Coronary Intravascular Lithotripsy (IVL) Catheter
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,212
- 试验地点
- 1
- 主要终点
- Number of Participants With IVL-related Ventricular Arrhythmia
研究概览
简要总结
The study design is a prospective, multicenter, observational, single-arm post-approval study using data collected in the National Cardiovascular Data Registry (NCDR®) CathPCI Registry®.
详细描述
Subject Population: Patients ≥18 years of age with severely calcified, stenotic de novo coronary artery lesions presenting with stable, unstable, or silent ischemia that are suitable for percutaneous coronary intervention (PCI) and with clinical characteristics similar to the Disrupt CAD III IDE study. Approximately 1000 patients in the CathPCI Registry® (including a minimum of 30 patients with permanent pacemakers [PPM] or implantable cardioverter defibrillators [ICDs]) will be enrolled. Subjects will be followed through discharge.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Subject is ≥18 years of age
- •Subjects with native coronary artery disease (including stable or unstable angina and silent ischemia) suitable for PCI
- •Left ventricular ejection fraction >25% within 6 months
- •The target lesion must be a de novo coronary lesion that has not been previously treated with any interventional procedure
- •LAD, RCA or LCX (or of their branches) with:
- •Stenosis of ≥70% and <100% or
- •Stenosis ≥50% and <99% (visually assessed) with evidence of ischemia via positive stress test, or fractional flow reserve (FFR) value ≤0.80, or iFR <0.90 or IVUS or OCT minimum lumen area ≤4.0 mm²
- •The lesion length must not exceed 40 mm
- •The target vessel must have TIMI flow 3 at baseline (visually assessed; may be assessed after pre-dilatation)
- •Evidence of calcification at the lesion site by angiography, with fluoroscopic radio-opacities noted without cardiac motion prior to contrast injection involving both sides of the arterial wall in at least one location
排除标准
- •Subject experienced an acute MI (STEMI or non-STEMI) within 30 days prior to index procedure
- •New York Heart Association (NYHA) class III or IV heart failure
- •Renal failure with serum creatinine >2.5 mg/dL or chronic dialysis
- •Subjects in cardiogenic shock or with clinical evidence of acute heart failure
- •Target lesion is located in a native vessel that can only be reached by going through a saphenous vein or arterial bypass graft
- •Previous stent within target lesion (in-stent restenosis)
结局指标
主要结局
Number of Participants With IVL-related Ventricular Arrhythmia
时间窗: Up to hospital discharge, approximately 24-48 hours
All-cause Death Rate
时间窗: Up to hospital discharge, approximately 24-48 hours
Number of Participants With Procedure-related Adverse Events
时间窗: Up to hospital discharge, approximately 24-48 hours
Number of Participants With IVL Balloon Loss of Pressure/Rupture
时间窗: Up to hospital discharge, approximately 24-48 hours
Number of IVL-related Pacing Issues in Patients With PPM/ICD
时间窗: Up to hospital discharge, approximately 24-48 hours
Events that may indicate an adverse device interaction including inappropriate inhibition of pacing during IVL device utilization, inappropriate ICD shock during IVL device utilization (for ICD patients only), and the need for device re-programming associated with IVL use (during or post procedure).
Number of Participants With Serious Coronary Dissection Following Balloon Loss of Pressure/Rupture
时间窗: Up to hospital discharge, approximately 24-48 hours
次要结局
未报告次要终点