Status:
COMPLETED
STaged Interventional Strategies for Acute ST-seGment Elevation Myocardial Infarction Patient With Multi-vessel Disease（STAGED）
Lead Sponsor:
Xiamen Cardiovascular Hospital, Xiamen University
Collaborating Sponsors:
Nanjing First Hospital, Nanjing Medical University
Conditions:
STEMI
Multi Vessel Coronary Artery Disease
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
An investigator-initiated, randomized, multicenter, two-arm, open-label study of consecutive patients presenting with STEMI and MVD Objectives: The present study aimed to investigate the difference in...
Detailed Description
A total of 1586 subjects with STEMI who met inclusion criteria and had no any exclusion criterion will be randomized (at a 1:1 ratio) to Early staged PCI group and Late staged PCI group. After success...
Eligibility Criteria
Inclusion
- Provision of informed consent prior to any study specific procedures;
- Established indication to PPCI according to the guidelines of American Heart Association and American College of Cardiology;
- Spontaneous acute STEMI (patients presenting within 24 hours of symptom onset) with MVD after successful revascularization of the culprit artery;
- De novo coronary lesion,
- TIMI Flow 3 ( Cases with TIMI flow 2 need to perform angiographic again in 24h ensured TIMI flow 3 for enrolling case )after revascularization of the culprit artery, residual stenosis ≤20% and no coronary dissection greater than or equal to type C leading to (threatening) vessel closure.
- At least one non-culprit coronary stenosis ≥ 80% and accompanied by QFR ≤0.8 in a vessel with a lumen diameter ≥2.5;
Exclusion
- Age \<18 yr and \>80 yr;
- Cardiac shock, multiple organ failure, cerebral hemorrhage, severe aortic stenosis and myocardial infarction complications(cardiac rupture, ventricular septal rupture and papillary muscle rupture);
- Killip classification \>3, cardiognic shock, shore-infarction of culprit artery after emergency PCI in 24 hours;
- Previous documented allergic reaction to drug and device of this study;
- Planned major surgery within 6 weeks in which impact DAPT;
- Participation in another clinical study, interfering with this protocol Uncertain;
- Life expectancy \< 1 year;
- Any condition likely to interfere with study processes including follow-up visits or increase of risk accessed by researcher.
Key Trial Info
Start Date :
February 11 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2025
Estimated Enrollment :
1586 Patients enrolled
Trial Details
Trial ID
NCT04918030
Start Date
February 11 2021
End Date
February 1 2025
Last Update
December 12 2025
Active Locations (1)
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1
Xiamen Cardiovascular Hospital Xiamen University
Xiamen, Fujian, China, 361000