the Effect of Prolonged Inflation Time During Drug-eluting Stents Deployment Compared With Conventional Method for ST-elevation Myocardial Infarction
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- corrected TIMI frame count(frames)
研究概览
简要总结
The purpose of this study is to determine whether prolonged inflation time on drug-eluting stents deployment for ST-elevation myocardial Infarction was better than conventional stents deployment.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •men and women ≥18 years with ST-elevation Myocardial Infarction;
- •patients with STEMI and ischemic symptoms of less than 12 hours'duration;
- •patients with STEMI and ischemic symptoms of less than 12 hours' duration who have contraindications to fibrinolytic therapy, irrespective of the time delay from FMC;
- •patients with STEMI if there is clinical and/or ECG evidence of ongoing ischemia between 12 and 24 hours after symptom onset;
- •when angiography was completed, guide wire could cross the lesion in the culprit vessel, TIMI≥1，with feasibility to direct stenting
排除标准
- •cardiac shock, or acute severe heart failure;
- •the lesion was highly calcified, excessive proximal tortuosity,left main artery lesion, restenosis lesion,vein graft lesion,total occlusions;
- •True bifurcation lesions;
- •Stenosis≤50% and TIMI flow grade 3;
- •history of PCI in target vessel;
- •diameter of the target vessel less than 2 mm;
- •severe liver and kidney dysfunction;
- •inability to give informed written consent.
研究组 & 干预措施
prolonged deployment strategy group
in "deploying the Drug-eluting Stents with a prolonged time" group,the inflation time was more than 30 seconds when the Drug-eluting Stents deploying,unless the patients was unstable.
干预措施: deploying the Drug-eluting Stents with a prolonged time (Device)
rapid deployment strategy group
in "deploying the Drug-eluting Stents with a conventional time" group, a conventional method was used to deploying drug-eluting stents,the actual inflation time was within 10s determined by interventional cardiologist.
干预措施: deploying the Drug-eluting Stents with a conventional time (Device)
结局指标
主要结局
corrected TIMI frame count(frames)
时间窗: 1 minute after sent was deployed
Grading was done on cinefilm at 15frames/s made in a Philips digital coronary imaging catheterization laboratory.
Number of Participants With TIMI 3
时间窗: 1 minute after sent was deployed
TIMI 0 flow (no perfusion) refers to the absence of any antegrade flow beyond a coronary occlusion.TIMI 1 flow (penetration without perfusion) is faint antegrade coronary flow beyond the occlusion, with incomplete filling of the distal coronary bed.TIMI 2 flow (partial reperfusion) is delayed or sluggish antegrade flow with complete filling of the distal territory.TIMI 3 is normal flow which fills the distal coronary bed completely
myocardial blush grade
时间窗: 1 minute after sent was deployed
0, no myocardial blush or contrast density; 1, minimal myocardial blush or contrast density; 2,moderate myocardial blush or contrast density but less than that obtained during angiography of a contralateral or ipsilateral non- infarct-related coronary artery; and 3, normal myocardial blush or contrast density, comparable with that obtained during angiography of a contralateral or ipsilateral non-infarct-related coronary artery
次要结局
- Number of Participants Death from cardiac causes(one month after the operation)
- Number of Participants stent thrombosis(one month after the operation)
- Number of Participants had Major bleeding(one month after the operation)
- Number of Participants ST-segment resolution(60min after the operation)
- Number of Participants Target-vessel revascularization(one month after the operation)