NCT06502938尚未招募不适用
To Evaluate Percutaneous Coronary Intervention Assisted by the Control System of Panvascular Interventional Surgery Efficacy and Safety Clinical Trials
Shenzhen Institute of Advanced Biomedical Robot Co., Ltd.7 个研究点 分布在 1 个国家目标入组 159 人开始时间: 2024年7月15日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 159
- 试验地点
- 7
- 主要终点
- Clinical Success
研究概览
简要总结
The purpose of this prospective, randomized, open, parallel controlled, multicenter trial is to investigate the efficacy and safety of the pan-vascular interventional robotic system for percutaneous coronary intervention (PCI). Investigators will evaluate clinical success, technical success, and record intraoperative data (PCI time, total operating time, contrast agent dose, radiation exposure dose, etc.). All subjects were followed up on the day of surgery, before discharge and 1 month after surgery to observe the safety indicators.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •1. General Inclusion criteria:
- •18 years old ≤ age ≤85 years old;
- •have a clinical indication for PCI (clinical evidence of ischemic heart disease or a positive functional study);
- •Subject or guardian can understand the purpose of the experiment and sign informed consent voluntarily Book and willing to cooperate to complete the follow-up.
- •2. Angiographic inclusion criteria:
- •The stenosis degree of visual target lesion ≥50%;
- •2.5mm≤ Visual target vessel diameter ≤4.0mm;
- •Visual target lesions ≤38mm in length, or successive small lesions that can be completely covered by a single stent;
- •Target lesions to be treated intraoperatively cannot be treated in stages.
排除标准
- •General exclusion criteria 1)A stroke occurred within 30 days prior to surgery; 2)Percutaneous coronary intervention was performed within 72 hours before surgery; 3)Acute myocardial infarction, cardiogenic shock, or infarction occurred within 48 hours before surgery Received CPR; 4)Other cardiac procedures (such as aortic valve placement) are scheduled within 30 days of surgery Coronary artery bypass grafting, etc.); 5)Pregnant or lactating female subjects; 6)Severe hepatic or renal insufficiency or bleeding tendency; 7)Known allergy to interventional device materials and their coatings, or allergy to contrast agents; 8)Severe stenosis, occlusion of blood vessels at the intended puncture site, or local skin infection and uncontrollable; 9)Are participating in other interventional clinical studies, and have not completed the evaluation of the primary endpoint of the relevant study; 10)Participants who had other contraindications for interventional therapy or were judged by the investigator to be unsuitable for participation in the study;
- •Angiographic exclusion criteria 1)The TIMI blood flow grade of the target lesion was < 2; 2)Treatment requiring intrastent restenosis, or prior placement of a stent in the target vessel near both ends of the target lesion; 3)Severe tortuosity or severe calcification of blood vessels; 4)There's an intracavitary thrombus; 5)In addition to balloon forming and stent implantation, other treatments (such as atheromatectomy, rotary grinding, laser ablation, etc.) are also required at the same time; 6)The researchers determined that percutaneous coronary intervention was not suitable for robotic assistance or that there might be high risks in the process.
结局指标
主要结局
Clinical Success
时间窗: Discharge or 48 hours post intervention, whichever comes first
No MACE occurred in hospital.
次要结局
- Fluoroscopy Time(Procedure)
- Contrast agent dosage(Procedure)
- Procedure Time(Procedure)
- Technical success rate(Procedure)
- PCI time(Procedure)
- the Pan-vascular Interventional Robotic Systemt performance evaluation(After the operation)
- Radiation Exposure(Procedure)
研究者
Ge Junbo
Chief of Cardiology
Shanghai Zhongshan Hospital
研究点 (7)
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