CorPath GRX With ReMOTE Proof of Principle (POP): First in Human in India
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Device Technical Success
研究概览
简要总结
To evaluate the safety and performance of CorPath GRX POP System, in the ReMOTE (location outside hospital) delivery and manipulation of coronary guidewires and stent/balloon catheters, and manipulation of guide catheters during PCI procedures.
详细描述
Prospective, single-arm, single center, non-randomized feasibility study of the CorPath GRX POP System to examine its performance during remote angioplasty (ballooning) and stenting and patient outcomes through 48 hours post-PCI procedure hospital discharge, whichever occurs first.
研究设计
- 研究类型
- Interventional
- 干预模型
- Sequential
- 主要目的
- Device Feasibility
- 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
- 是
入选标准
- •Age ≥18 years;
- •Patients with coronary artery disease with clinical indication for PCI;
- •Patient deemed appropriate for robotic-assisted PCI; and
- •The subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.
- •Angiographic Inclusion:
- •Study lesion is a single de novo native coronary artery lesion (i.e. a coronary lesion not previously treated).
- •The lesion reference vessel diameter is between 2.50 mm and 4.0 mm by visual estimate.
- •Study lesion length less or equal to 20 mm by visual estimate.
- •The study lesion length can be treated with one stent. The stent should be able to cover the whole length of the lesion with at least 2 mm of normal segments on proximal and distal edges of the lesion.
- •Study lesion diameter showing significant stenosis of at least 50% by visual estimate.
排除标准
- •Failure/inability/unwillingness to provide informed consent; or
- •The investigator determines that the patient or the coronary anatomy is not suitable for robotic-assisted PCI.
- •Angiographic Exclusion:
- •Target lesion that cannot be fully covered by a single stent.
- •Subject requires treatment of multiple lesions
- •Any previous stent placement within 5 mm (proximal or distal) of the target lesion
- •The study lesion requires planned treatment with DCA, laser, rotational atherectomy, or any device except for balloon dilatation prior to stent placement
- •The study vessel has evidence of intraluminal thrombus or moderate to severe tortuosity (> 90°) proximal to the target lesion
- •The study lesion has any of the following characteristics:
- •Total occlusion
- •Within 2mm of a side branch > 2.0 mm vessel diameter
- •Not ostial in location
- •Is located at ≥ 45° bend in the vessel
- •Is severely tortuous
- •Is severely calcified
- •Severe calcification at the part of the vessel proximal to target lesion
- •Target lesion that is located in a native vessel distal to an anastomosis with a saphenous vein graft or a left/right internal mammary artery (LIMA/RIMA) bypass and is approached through the by-pass graft
- •Unprotected left main coronary artery disease (an obstruction greater than 50% diameter stenosis in the left main coronary artery)
结局指标
主要结局
Device Technical Success
时间窗: Measured from guide catheter in time through procedure end time (or guide catheter out time).
Defined as completing the robotic PCI entirely with the CorPath GRX POP System.
In-hospital MACE
时间窗: Measured from Sheath in time to discharge or 48 hours, whichever occurs first.
Recording any MACE event that occurred from the time the sheath was inserted through 48 hours post procedure or hospital discharge, whichever of the two occurred first.
次要结局
- Clinical Procedural Success(Measured from guide catheter in time through procedure end time (or guide catheter out time).)
- All Serious Adverse Events(Measured from Sheath in time to discharge or 48 hours, whichever occurs first.)