Prospective Multi-Center, Single Arm Study of the Shockwave Coronary Rx Lithoplasty® System in Coronary Arteries
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 7
- 主要终点
- Safety - Frequency of Major Adverse Cardiac Events (MACE) Within 30 Days of the Procedure.
研究概览
简要总结
Prospective, multi-center, single arm study designed to evaluate the safety and performance of the Shockwave Coronary Rx Lithoplasty® System to treat calcified lesions in the coronary arteries for the purpose of enhancing the placement of stents and reducing the ultimate residual stenosis. Patients will be followed through discharge and at 30 and 180 days.
详细描述
Prospective, multi-center, single arm study designed to evaluate the safety and performance of the Shockwave Coronary Rx Lithoplasty® System to treat calcified lesions in the coronary arteries for the purpose of enhancing the placement of stents and reducing the ultimate residual stenosis. Patients will be enrolled and consented in the study based on history and in some instances an angiogram obtained prior to the study. The study is designed to demonstrate that the Shockwave device can safely and effectively deliver localized shockwave energy for balloon dilatation of calcified, stenotic, coronary arteries. Subjects will be prepared for PCI per the institution's standard protocol. Medications will be administered per the treatment protocol. Femoral access will be obtained using a 6F access sheath, and guiding catheter placed at the ostia of the right or left coronary artery. Baseline angiography of the culprit lesion will be performed prior to placement of a 0.014" guide wire. Baseline and either IVUS or OCT will be performed to determine the Maximum Lumen Area (MLA), percent stenosis, and volumetric lesion assessment. Baseline angiography will be performed to determine lesion length, % stenosis and reference vessel diameter. The investigational device will be prepped per the IFU and positioned at the target lesion. The distal end of the balloon catheter will be connected to the patient cable. The balloon catheter will be inflated to 4 atm and the investigator will deliver 10 pulses for 20 seconds. The balloon will then be inflated to reference vessel diameter and then deflated to reestablish flow and complete one treatment cycle. The treatment cycle will then be repeated. Angiography and either IVUS or OCT will be repeated for the treated lesion.. A coronary stent will be deployed at the site of treatment. Angiography and either IVUS or OCT will be performed following stent placement. Patients will be followed through discharge and at 30 and 180 days. A subset of up to five (5) subjects will receive an angiographic assessment at the 180 day follow up visit, per the Sponsor's discretion.
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 12 hours prior to the procedure
- •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 lesions 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
- •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 elevated Troponin-I or T (with concomitant elevation of CPK) at the time of enrollment.
- •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
研究组 & 干预措施
Lithoplasty System
Shockwave Coronary Rx Lithoplasty® System is a lithotripsy-enhanced, low-pressure balloon dilation of calcified, stenotic de novo coronary arteries prior to stent placement
干预措施: Shockwave Coronary Rx Lithoplasty® System (Device)
结局指标
主要结局
Safety - Frequency of Major Adverse Cardiac Events (MACE) Within 30 Days of the Procedure.
时间窗: 30 days
MACE defined as: * 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 the target lesion) after the completion of the index procedure
Performance
时间窗: Post-procedure (within 24 hours following procedure and prior to discharge)
The ability of the Shockwave System to produce acceptable residual stenosis (\<50%) after stenting with no evidence of in-hospital MACE. Clinical success measured by each patient that achieves both these requirements.
次要结局
- Quantitative Assessment of the Residual Stenosis in Treated Lesions(Post-procedure (within 24 hours following procedure and prior to discharge))
- 180 Day MACE(180 days post-procedure)