Prospective Multi-Center, Single Arm Post-Market Study (PMS) of the Shockwave Medical, Inc. Coronary Lithoplasty® System in Coronary Arteries
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 15
- 主要终点
- Number of Participants With In-hospital Major Adverse Cardiac Events (MACE)
研究概览
简要总结
The objective of this post market study is to examine the safety and performance of the Shockwave Coronary Intravascular Lithotripsy System for the treatment of narrowed coronary arteries before the doctor places a stent.
详细描述
The study will be conducted at 15 sites in Europe and up to 120 participants will be followed for 30 days post procedure.
Patients ≥18 years of age scheduled for stent procedure with evidence of significant calcified stenosis of left main, or left anterior descending, right coronary artery or left circumflex will be eligible to enroll in the study. The primary endpoint of the study will evaluate major adverse cardiac events post procedure including 1) cardiac related death, 2) heart attack, and 3) intervention to treat the coronary artery that was previously treated at the procedure visit.
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
- •Patient is ≥ 18 years of age
- •Troponin must be less than or equal to the upper limit of lab normal value within 24 hours prior to the procedure OR if troponin is elevated, concomitant CK must be normal
- •The target vessel must have a TIMI flow 3 at baseline
- •Patients with significant (≥ 50% diameter stenosis) native coronary artery disease including stable or unstable angina and silent ischemia, suitable for PCI
- •Ability to tolerate dual antiplatelet agent (i.e. aspirin, clopidogrel, prasugrel, or ticagrelor) for 1 year and single antiplatelet therapy for life
- •Single lesion stenosis of protected LMCA, or LAD, RCA or LCX artery ≥50% in a reference vessel of 2.5 mm - 4.0 mm diameter and ≤ 32 mm length
- •Presence of calcification within the lesion on both sides of the vessel as assessed by angiography
- •Planned treatment of single lesion in one vessel
- •Ability to pass a 0.014" guide wire across the lesion
- •Patient, or authorized representative, signs a written Informed Consent form to participate in the study, prior to any study-mandated procedures
- •Patient is able and willing to comply with all assessments in the study
排除标准
- •Concomitant use of Atherectomy, Specialty balloon, or investigational coronary devices
- •Prior PCI procedure within the last 30 days of the index procedure
- •Patient has planned cardiovascular interventions within 30 days post index procedure
- •Second lesion with ≥50% stenosis in the same target vessel
- •Left ventricular ejection fraction < 40%
- •Patient refusing or not a candidate for emergency coronary artery bypass grafting (CABG) surgery
- •Uncontrolled severe hypertension (systolic BP >180 mm Hg or diastolic BP >110 mm Hg)
- •Severe renal failure with serum creatinine >2.5 mg/dL, unless on chronic dialysis
- •Untreated pre-procedural hemoglobin <10 g/dL
- •Coagulopathy manifested by platelet count <100,000 or International Normalized ratio (INR) >1.7 (INR is only required in patients who have taken warfarin within 2 weeks of enrollment)
- •Patients in cardiogenic shock
- •Acute myocardial infarction (MI) within the past one (1) month, and/or signs of active myocardial ischemia at the time of enrollment including elevated Troponin-I or T (with concomitant elevation of CK), ischemic ECG changes or chest pain
- •History of a stroke or transient ischemic attack (TIA) within 3 months
- •NYHA class III or IV heart failure
- •Active peptic ulcer or upper gastrointestinal (GI) bleeding within 6 months
- •Patients with a life expectancy of less than 1 year
- •Target vessel < 2.4 mm in diameter
- •Target lesion > 32 mm in length
- •Chronic Total Occlusion (CTO)
- •Previous stent procedure within 5 mm of target lesion
- •Angiographic evidence of a target lesion severe dissection prior to Coronary Lithoplasty treatment
- •Unprotected Left Main diameter stenosis ≥ 50%
- •Visible thrombus (by angiography) at target lesion site
- •Target lesion is located in a native vessel distal to anastomosis with a saphenous vein graft or LIMA/RIMA bypass
- •Patient has active systemic infection
- •Patient has connective tissue disease (e.g., Marfan's syndrome)
- •Patient has a hypercoagulable disorder
- •Uncontrolled insulin dependent diabetes
- •Patient has allergy to imaging contrast media for which they cannot be pre-medicated
- •Evidence of aneurysm in target vessel
- •Patient is pregnant or nursing
结局指标
主要结局
Number of Participants With In-hospital Major Adverse Cardiac Events (MACE)
时间窗: Post-procedure through hospital discharge
The primary endpoint is the frequency of in-hospital major adverse cardiac events (MACE). MACE is defined as the following: * Cardiac death * Myocardial Infarction - defined as a CK-MB level \> 3 times the upper limit of lab normal (ULN) value with or without new pathologic Q wave * TVR - defined as revascularization at the target vessel (inclusive of the target lesion) after the completion of the index procedure
次要结局
- Number of Participants With Clinical Success(During procedure through hospital discharge)
- Number of Participants With Angiographic Success(During procedure)
- Number of Participants Which Experienced Cardiac Death(30 days post-procedure)