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

Sichuan University

Status: Unknown

Conditions: Acute ST-elevation Myocardial Infarction

Treatments: Device: deploying the Drug-eluting Stents with a conventional time; Device: deploying the Drug-eluting Stents with a prolonged time

Study type: Interventional

Funder types: Other

Identifiers

NCT03199014

WestChinaH-CVD-001

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

prolonged deployment strategy group

Experimental group

Description:

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.

Treatment:

Device: deploying the Drug-eluting Stents with a prolonged time

rapid deployment strategy group

Active Comparator group

Description:

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.

Treatment:

Device: deploying the Drug-eluting Stents with a conventional time