the Effect of Prolonged Inflation Time During Stents Deployment for ST-elevation Myocardial Infarction

Study Overview
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Brief Summary
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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.

Official Title
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the Effect of Prolonged Inflation Time During Drug-eluting Stents Deployment Compared With Conventional Method for ST-elevation Myocardial Infarction

Conditions
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Acute ST-elevation Myocardial Infarction

Intervention / Treatment
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* Device: deploying the Drug-eluting Stents with a prolonged time
* Device: deploying the Drug-eluting Stents with a conventional time


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: prolonged deployment strategy group<br>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. | Device: deploying the Drug-eluting Stents with a prolonged time<br>* the inflation time was more than 30 seconds when the Drug-eluting Stents deploying.The PROMUS Element Plus Stent or Co-Cr sirolimus-eluting coronary stent system（GuReater）was used in this study<br>|
| Active Comparator: rapid deployment strategy group<br>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. | Device: deploying the Drug-eluting Stents with a conventional time<br>* the actual inflation time was within 10s determined by interventional cardiologist.The PROMUS Element Plus Stent or Co-Cr sirolimus-eluting coronary stent system（GuReater）was used in this study<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With TIMI 3 | 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 | 1 minute after sent was deployed | 
| corrected TIMI frame count(frames) | Grading was done on cinefilm at 15frames/s made in a Philips digital coronary imaging catheterization laboratory. | 1 minute after sent was deployed | 
| myocardial blush grade | 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 | 1 minute after sent was deployed | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants ST-segment resolution | 1, normalized, defined as no residual ST-segment elevation; 2, improved, defined as a residual ST-segment elevation ,70% of with that on the first ECG; and 3, unchanged, defined as a residual ST-segment elevation 70% of that on the first ECG | 60min after the operation | 
| Number of Participants Death from cardiac causes | death from acute myocardial infarction, cardiac perforation, or pericardial tamponade; an arrhythmia or conduction abnormality; complications of the interventional procedure at baseline | one month after the operation | 
| Number of Participants Target-vessel revascularization | any revascularization intervention (PCI or CABG) occurring in a treated vessel at any time after the index intervention. | one month after the operation | 
| Number of Participants stent thrombosis | evidence of any myocardial infarction with angiographic confirmation of in-stent thrombus or unexplained death within 30 days after the procedure as stent thrombosis | one month after the operation | 
| Number of Participants had Major bleeding | any symptomatic intracranial hemorrhage, or clinically overt signs of hemorrhage (including imaging) associated with a drop in hemoglobin of>= g/dL (or when the hemoglobin concentration is not available, an absolute drop in hematocrit of>=15%) | one month after the operation |