NCT07010094招募中不适用
A Prospective, Multicenter, Single-arm, Target-Value Clinical Trial to Evaluate the Safety and Efficacy of BM Shockwave Devices to Treat Coronary Calcified Lesions
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 198
- 试验地点
- 2
- 主要终点
- Procedure success rate
研究概览
简要总结
This clinical trial is a prospective, multicenter, single-arm, target-value study to verify the safety and efficacy of BM coronary shockwave devices for the treatment of coronary calcification lesions.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •General inclusion criteria:
- •Age 18-85 years, male or female;
- •Patients with evidence of asymptomatic ischemia, stable or unstable angina, or old myocardial infarction;
- •Patient is able and willing to comply with all assessments in the study.
- •Angiography inclusion criteria:
- •The target lesion is a de novo, in-situ coronary artery lesion;
- •The target lesion length is ≤40 mm, and the target lesion reference vessel diameter is 2.0-4.0 mm (visual estimation);
- •The target lesion diameter stenosis is visually estimated to be ≥70%, or <70% but ≥50% with evidence of ischemia;
- •Clear high-density calcification shadows are visible both during cardiac contraction and at rest;
- •Target vessel TIMI flow grade 3 prior to use of the investigational device (pre-dilatation is permitted);
- •The target lesion is the only calcified lesion to be treated with shock wave therapy in this session; if non-target lesions are present, they must be successfully treated prior to the target lesion;
- •Patients suitable for treatment with metal stent implantation.
排除标准
- •General exclusion criteria:
- •ST-segment elevation myocardial infarction within 3 days prior to the procedure;
- •Use of rotational atherectomy or special balloons (chocolate balloon, scoring balloon, cutting balloon, etc.) for lesion pretreatment;
- •New York Heart Association (NYHA) functional class III or IV;
- •Target lesion expected to require full biodegradable scaffold implantation, drug-eluting balloon dilation, or percutaneous transluminal coronary angioplasty (PTCA) treatment;
- •Uncontrolled severe hypertension (persistent: systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg);
- •Severe liver or kidney dysfunction, with transaminase levels exceeding three times the upper limit of normal, serum creatinine >2.5 mg/dL (221 μmol/L), or chronic kidney failure requiring long-term dialysis;
- •Platelet count <60 × 10⁹/L;
- •Stroke within the past 6 months prior to enrollment, excluding transient ischemic attack (TIA) and lacunar infarction;
- •Active peptic ulcer or history of upper gastrointestinal bleeding within the past 6 months prior to enrollment;
- •Known allergy to heparin, contrast agents, aspirin, clopidogrel, or anesthetics;
- •Patients with a life expectancy of less than 12 months due to severe medical conditions;
- •Patients who have participated in other drug or device clinical trials and failed to meet the primary endpoint;
- •Pregnant or breastfeeding women;
- •Patients deemed by the investigator to have poor compliance and unable to complete the study according to the protocol.
- •Contrast exclusion criteria:
- •The target lesion and non-target lesion are in the same vascular branch;
- •The target lesion is at the origin (LAD, LCX, or RCA, within 5 mm of the origin) or an unprotected left main lesion;
- •A stent has been implanted within 10 mm of the proximal or distal end of the target lesion;
- •The target lesion has an unprotected branch vessel with a diameter of 2.5 mm or greater;
- •The target lesion is located distal to the saphenous vein or LIMA (left internal mammary artery)/RIMA (right internal mammary artery) bypass graft;
- •An aneurysm is present within 10 mm of the target lesion;
- •Contrast imaging confirms the presence of an NHLBI classification D-F type arterial dissection at the target lesion prior to the use of the investigational device;
- •The target lesion has definite thrombus formation;
- •The investigator determines that the target lesion is not suitable for vascular dilation in the patient.
结局指标
主要结局
Procedure success rate
时间窗: Endpoints will be measured through hospital discharge (expected to be within 7 days)
Definition: Residual stenosis ≤30% after PCI, and no major adverse cardiac events (MACE) events occurring during hospitalization. MACE is defined as cardiac death, myocardial infarction, and target vessel revascularization events.
次要结局
- Angiography success rate(0 day)
- Residual stenosis(0 day)
- Device success rate(0 day)
- MACE rate(30 days)
- Target lesion failure(30 days)
- Device defects(0 day)
研究者
研究点 (2)
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