NCT06787547已完成不适用
A Prospective, Multi-center, Single-arm, Objective Performance Goal Pre-specified Study to Evaluate the Safety and Effectiveness of Intravascular Lithotripsy Generator Combined with SONICO-CX Coronary Intravascular Lithotripsy (IVL) Catheter for Pre-treatment of Coronary Calcification Before Stent Implantation
Spectrumedics Medical Technology(Shanghai)Co.,Ltd11 个研究点 分布在 1 个国家目标入组 266 人开始时间: 2021年12月1日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 266
- 试验地点
- 11
- 主要终点
- Procedural success rate
研究概览
简要总结
This study is a prospective, multicenter, single-arm trial designed to investigate the effectiveness and safety of this intravascular lithotripsy system to treat severely calcified coronary lesions before stenting.
详细描述
Subject Population: Subjects ≥ 18 years of age with de novo, calcified coronary artery lesions presenting with stable, unstable or silent ischemia that are suitable for percutaneous coronary intervention (PCI). 266 subjects at 11 sites will be enrolled.Subjects will be followed through discharge, 30 days, 6months.
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
- •General inclusion criteria
- •Age ≥ 18 years old
- •Evidence of asymptomatic ischemia, stable or unstable angina
- •Patients who can understand the purpose of the trial, voluntarily participate and sign informed consent, and are willing to undergo angiography, OCT, and clinical follow-up.
- •Angiographic Inclusion Criteria
- •The target lesion must be a de novo coronary lesion that has not been previously treated with any interventional procedure
- •Length of the target lesion ≤60mm, diameter of the target lesion 2.5-4.0mm
- •Target lesion diameter stenosis ≥70%, the doctor determines the need for stent implantation
- •The lesion allows 0.014 guide wires to pass through
- •Under multi-angle contrast conditions, it can be seen that there are calcified angiography lesions on both sides of the lesion blood vessel wall (the target lesion meets the definition of severe calcification).
排除标准
- •General inclusion criteria
- •Patients who fit any of the following criteria were excluded:
- •Acute myocardial infarction occurred within 30 days before procedural
- •Simultaneous use of spinning or special balloons (chocolate balloons, scoring balloons, spinous balloons, etc.) to treat the lesion
- •Troponin was 5 times greater than the upper limit of laboratory normal within one week before procedural
- •Severe cardiac insufficiency (Grade III or IV)
- •Left ventricular ejection fraction < 40%
- •The patient refuses emergency CABG surgery or does not have indications for emergency CABG surgery.
- •Uncontrolled severe hypertension (ystolic blood pressure >180 mm Hg or diastolic blood pressure >110 mm Hg)
- •Severe renal failure (serum creatinine > 221μmol/L)
- •Preprocedural hemoglobin < 100g/L
- •Significant coagulation dysfunction (platelet count < 100×109/L or INR>1.7, INR is only required for patients who have taken warfarin orally within 2 weeks prior to enrollment)
- •Hypercoagulable blood disorders (e.g. Polycythemia vera, platelet count >750× 109/L, etc.)
- •History of stroke or TIA within 3 months
- •History of active digestive ulcer or upper gastrointestinal bleeding within 6 months
- •The patients has a life expectancy of less than 12 months
- •The patient has an active systemic infection
- •The patient has a connective tissue disease (such as Marfan's syndrome)
- •The patient is allergic to contrast material
- •Patients undergoing heart transplantation
- •Patients with pacemakers implanted
- •The patient is pregnant or breastfeeding
- •Those who have participated in clinical trials of other drugs or medical devices within 1 month before enrollment
- •Other circumstances that the investigator deems inappropriate to participate in the trial - Angiographic Exclusion Criteria
- •Patients who met any of the following criteria were excluded:
- •Unprotected left main disease (left main visual stenosis > 50%)
- •Baseline TIMI blood flow less than grade 3 (allows evaluation after pre-dilation)
- •A stent has been implanted within 10mm of the proximal or distal end of the target lesion
- •The target lesion is located at the distal end of the saphenous vein or LIMA/RIMA bypass graft
- •Aneurysm within the target blood vessel
- •Angiography confirmed the presence of thrombus in the target vessel
- •Chronic total occlusive lesions
- •Angiography confirmed the presence of severe dissection of the target lesion prior to hydroelectric shock wave lithotripsy treatment (D-F dissection (NHLBI classification)）
- •The investigators determined that the target lesion was unsuitable for patients undergoing vasodilation
结局指标
主要结局
Procedural success rate
时间窗: During hospitalization (up to 7 days after operation)
defined as successful stent implantation with ≤30% in-stent residual stenosis and the absence of in-hospital MACE, including cardiac death, MI, and target vessel revascularization
次要结局
- Angiography success rate(Immediately after operation)
- Device success rate(Immediately after operation)
- MACE events(before discharge, 30 days and 6 months post-procedural)
研究者
研究点 (11)
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