R-One Efficiency For PCI Evolution With Robotic Assistance
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Robocath
- 入组人数
- 62
- 试验地点
- 12
- 主要终点
- Safety Endpoint: Number of patients with absence of Intra-procedural complications (Dissection, Thrombus, Air embolus, traumatic aorta)
研究概览
简要总结
This study is a Prospective, Multi-center, Single-arm clinical study, in patients with Coronary Artery Disease, including patients with silent ischemia (excluding STEMI), who qualify for elective Percutaneous Coronary Intervention (PCI), aimed to assess the Safety and Efficacy of the R-One device in elective PCI.
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
- •Age ≥18 years;
- •Candidate for PCI;
- •Presence of a de novo coronary artery stenosis of ≥ 50% and <100% in a native coronary artery indicated and suitable for stent implantation;
- •The vessel has a reference vessel diameter ranging from 2.5 mm to 4.0 mm;
- •The target lesion length allows for treatment with a single stent up to 38 mm in length;
- •Up to 2 target vessels each with a single target lesion requiring a single stent per lesion and treatable within a single procedure may be included (no further staged procedure allowed);
- •The patient provides written informed consent as approved by the applicable Ethics Committee and is willing to comply with all study requirements including 30 days follow-up.
排除标准
- •Target lesion has TIMI flow < 3;
- •Treatment of in-stent restenosis, or prior stent in the target vessel proximal to the target lesion;
- •More than one target lesion per vessel requiring treatment at the time of procedure;
- •Target lesion is a bifurcation requiring balloon or stent implantation of the side branch, with a side-branch RVD of ≥1.5 mm with a DS ≥50% at or within 5 mm its origin, or RVD ≥2.0 mm regardless of the presence of side branch disease;
- •Target lesion is located in left main coronary artery, or any left main stenosis > 30%;
- •Target lesion is within 5 mm of the ostial LAD, ostial LCX or ostial RCA;
- •Severe vessel tortuosity;
- •Severe vessel calcification;
- •STEMI, cardiopulmonary resuscitation or cardiogenic shock within 48 hours of the procedure;
- •Presence of visible thrombus;
- •Need for any procedure other than balloon angioplasty or stenting (e.g. atherectomy, laser, are excluded);
- •Patients under judicial protection, tutorship or curatorship (for France only);
- •Any patient participating in another clinical study evaluating a drug or a medical device (except registries for which the primary endpoint has not been evaluated;
- •Pregnant and breast-feeding women or intention to become pregnant prior to completion of all follow-up procedures.
结局指标
主要结局
Safety Endpoint: Number of patients with absence of Intra-procedural complications (Dissection, Thrombus, Air embolus, traumatic aorta)
时间窗: Peri-procedure
Absence of Intra-procedural complications (Dissection \>/= NHLBI type D, perforation, decrease of TIMI flow (\</= 2), acute occlusion, visible thrombus formation, significant air embolus, traumatic aortic or Left Main dissection by guiding catheter
Efficacy Endpoint: Number of Patients with Procedure technical success
时间窗: During Procedure
Procedure technical success defined as the successful advancement and retraction of all PCI devices (guidewires, balloon catheters and stents) and the successful treatment of all the target lesions using the R-One system and without conversion to manual operation
次要结局
- Contrast Volume in mL(During Procedure)
- Number of patients with Absence of each type of Intra-procedural complication (Dissection, Thrombus, Air embolus, traumatic aorta)(During Procedure)
- Procedure duration(During Procedure)
- Rate of Device Oriented Composite Criteria (Cardiovascular Death, Myocardial Infarction (peri-procedural and spontaneous), non clearly attributed to a non target or clinically driven target lesion revascularization)(Post-Procedure, 1 month)
- Robot duration(During Procedure)
- Radiation exposure using dosimeters (Patient Radiation, Robot Dose, Procedure Dose)(During Procedure)
- Rate of Bleeding or Vascular Complications(Up to 1 month)