jRCT2042230026已完成不适用
A multicenter, single-arm study to evaluate the safety and feasibility of PMA System for chronic total occlusion of coronary arteries
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 主要终点
- Penetration of guidewire into the distal true lumen of the CTO lesion
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 18age old over 至 80age old not（—）
- 性别
- All
入选标准
- •Submitted written consent to participate in the clinical trial of his/her own free will
- •Eighteen years of age or older and under 80 years of age at the time of consent
- •Has an eligible CTO
- •CTO is not located at the coronary ostium
- •The distal true lumen can be clearly visualized either by antegrade or contralateral injection
- •Distal lumen diameter of CTO is 1.0 mm or more
- •Has one of the following CTOs
- •One lesion (CTO) in one branch
- •Only 1 lesion can be treated with the investigational procedure if more than 2 CTOs
- •Meets PCI eligibility criteria and allows CABG and coronary stenting
- •Willing to undergo follow-up examinations and observations and able to visit the institution
排除标准
- •Heart rate not in 30 - 145 bpm range before PMA
- •Permanent pacemaker implanted
- •The target lesion of PMA is in the stent
- •No more than 8 weeks after coronary stenting, regardless of target CTO branch
- •Inability to take antiplatelet or anticoagulant therapy
- •Allergic to iodinated contrast media
- •Abnormal CK level or myocardial infarction in the past 72 hours
- •Has lesions in the deep veins of the lower extremities
- •Has a bleeding tendency or coagulopathy
- •Impossible to perform emergency blood transfusion
- •Serious gastrointestinal disease within 6 months before surgery
- •Historoy of cerebrovascular disease (such as cerebral infarction or hemorrhage) within 3 months before surgery
- •Pregnant, possibly pregnant or nursing
- •Has severe dementia, drug addiction or alcoholism
- •Has other serious illness
- •Life expectancy <1 years
- •Has participated in this clinical trial in the past
- •Determined to be unsuitable by the principal investigator or subinvestigator
结局指标
主要结局
Penetration of guidewire into the distal true lumen of the CTO lesion
Penetration of this investigational product's guidewire or conventional guidewire into the distal true lumen of the CTO lesion by the intended use of the investigational product
次要结局
未报告次要终点
研究者
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