NCT03927560Unknown不适用
Robotic-Assisted Percutaneous Coronary Intervention - A Safety and Effectiveness Study Applied to the Brazilian Public Health System
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 83
- 主要终点
- Procedure Success
研究概览
简要总结
Percutaneous coronary intervention is a safe procedure. However, its execution is manual, fully operator-dependent. The procedure is also associated with radiation exposure to patients and physicians. This study will evaluate the robotic assisted percutaneous coronary intervention as an alternative to manual operation.
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;
- •Symptomatic ischemic heart disease and / or objective evidence of myocardial ischemia with one or more target lesions;
- •Elective for percutaneous procedure (i.e. performed in a non-urgent context)
- •The target lesion (s) must be obstructive, with stenosis diameter > 50% (visual analysis);
- •The interventional planning of all target lesions should include robotic manipulation in at least one treatment, as judged by the operator;
- •Acceptable candidate for myocardial revascularization surgery.
排除标准
- •ST-segment elevation myocardial infarction in the last 48 hours before the index procedure;
- •Ejection fraction <30%;
- •Impaired renal function (creatinine> 2.0 mg / dL) or calculated creatinine clearance <30 ml / min;
- •Platelet count <100,000 cells / mm 3 or> 700,000 cells / mm 3;
- •Total Leucocytes count <3,000 cells / mm 3;
- •Suspected or documented active liver disease (including laboratory evidence of hepatitis);
- •Heart transplant recipient;
- •Allergies known to aspirin, clopidogrel, ticlopidine, ticagrelor, prasugrel, heparin, antiproliferative agents of the limus family, or stainless steel;
- •Patient with a life expectancy of less than 1 month;
- •Any significant medical condition that in the opinion of the investigator may interfere with the patient's ideal participation in this study;
- •Participation in other research in the last 12 months, unless there may be direct benefit to the research subject;
- •Any invasive cardiac or non-cardiac treatment scheduled within the first month after the index procedure.
- •Angiographic exclusion criteria
- •Need for non-robotic (i.e. manual) treatment of another injury in the index procedure or in the first month;
- •Target lesion not accessible by robotic treatment, according to the judgment of the operator;
- •Unprotected coronary artery trunk lesion (stenosis> 50%);
- •Angiographic thrombus;
- •Target lesion in surgical graft;
- •Total occlusion (TIMI 0 or 1 anterograde flow)
研究组 & 干预措施
Robotic Assisted Percutaneous Coronary Intervention
Experimental
干预措施: Robotic Assisted Percutaneous Coronary Intervention (Procedure)
结局指标
主要结局
Procedure Success
时间窗: 1 day
Robotic Assisted Procedure Success
Procedure Complications
时间窗: 1 day
Death or non-fatal major acute complications on the target vessel (thrombosis, myocardial infarction, perforation or non-planned invasive treatment).
次要结局
- Occurence of Major Events(1 month)
研究者
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已完成
2 期
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