Clinical trial NCT03199014: the Effect of Prolonged Inflation Time During Stents Deployment for ST-elevation Myocardial Infarction
Official title: the Effect of Prolonged Inflation Time During Drug-eluting Stents Deployment Compared With Conventional Method for ST-elevation Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute ST-elevation Myocardial Infarction
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2017-06-26
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants With TIMI 3
timeFrame: 1 minute after sent was deployed
measure: corrected TIMI frame count(frames)
timeFrame: 1 minute after sent was deployed
measure: myocardial blush grade
timeFrame: 1 minute after sent was deployed
Secondary outcomes:
measure: Number of Participants ST-segment resolution
timeFrame: 60min after the operation
measure: Number of Participants Death from cardiac causes
timeFrame: one month after the operation
measure: Number of Participants Target-vessel revascularization
timeFrame: one month after the operation
measure: Number of Participants stent thrombosis
timeFrame: one month after the operation
measure: Number of Participants had Major bleeding
timeFrame: one month after the operation
Other outcomes:
measure: Procedural time
timeFrame: form start puncturing vascular until the operation was completed intraoperative
measure: Radiation exposure time
timeFrame: form start puncturing vascular until the operation was completed intraoperative
Locations:
city: Chengdu
country: China
facility: West China Hospital
state: Sichuan
Study officials:
affiliation: west china hospital of sichuan univercity
name: He yong
role: STUDY_DIRECTOR
References:
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