NCT05967663

Fractional Flow Reserve Guided Immediate Versus Staged Complete Myocardial Revascularization in Patients With ST-segment Elevation Myocardial Infarction With Multivessel Disease (Future Study)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 840 (estimated)
• Sponsor: RenJi Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

It is a prospective, multicenter, randomised controlled, open-label, blinded endpoint assessment trial, to compare the strategy of immediate complete revascularisation and staged complete revascularisation in ST-segment-elevation myocardial infarction patients with multivessel coronary disease.

Detailed description

Objectives: The purpose of this study is to investigate whether FFR guided PCI strategy for non-culprit lesions should be attempted during the index procedure or staged in ST-segment-elevation myocardial infarction patients with multivessel coronary disease. Inclusion Criteria: 1. Age ≥ 18 years 2. Patients presenting STEMI and multivessel coronary disease successful primary PCI of the culprit lesion (including those who still have ischemic symptoms within 48 hours) 3. Multivessel disease was defined at least one non-culprit coronary arteries with a diameter of 2.5 mm or more and a maximum diameter at least 50% stenosis by visual estimation, PCI can be successfully implemented 4. Sign an informed consent form before participating in the study Exclusion Criteria: 1. Received thrombolytic therapy 2. Cardiac shock or SBP\<90mmHg; 3. History of old myocardial infarction; 4. Left main artery lesion, non infarct related vessels are CTO lesions; 5. PCI in the previous 30 days or Previous CABG 6. Patients who cannot give informed consent or have a life expectancy of less than 1 year 7. Patients combined with other serious diseases such as severe renal dysfunction (creatinine clearance value\<30ml/min;), liver dysfunction and thrombocytopenia 8. Patients with severe valve disease, hypertrophic cardiomyopathy, restrictive cardiomyopathy, and primary pulmonary hypertension; 9. Not suitable for clinical research: 1. . Currently participating in another study that may affect the primary endpoint 2. . Pregnant and lactating women; 3. . Known allergy to drugs that may be used in the study; 4. . Unable to comply with the trial protocol or follow-up requirements; Or the researcher believes that participating in the trial may result in patients facing greater risks.

Conditions

• ST Elevation Myocardial Infarction

Interventions

Type	Name	Description
DEVICE	PCI-immediate complete revascularisation	In patients allocated to the immediate complete revascularisation group, PCI of the culprit lesion was attempted first and followed by all other lesions deemed to be clinically significant by the operator during the index procedure.
DEVICE	PCI-staged complete revascularisation	In the staged complete revascularisation group, only the culprit lesion was treated during the index procedure and PCI of all non-culprit lesions deemed to be clinically significant by the operator was planned at a later stage through an elective re-admission within 15-45 days after randomisation.

Timeline

• Start date: 2023-11-11
• Primary completion: 2026-12-01
• Completion: 2028-12-01
• First posted: 2023-08-01
• Last updated: 2023-12-04

Locations

1 site across 1 country: China