NCT03562572

FFR Driven Complete Revascularization Versus Usual Care in NSTEMI Patients and Multivessel Disease

Ischemia (FFR) Driven Complete Revascularization Versus Usual Care in Patients With Non-ST Elevation Myocardial Infarction and Multivessel Diseases: The South Limburg Myocardial Infarction Study Group The SLIM Study

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 476 (estimated)
• Sponsor: Zuyderland Medisch Centrum · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

To compare FFR guided complete revascularization during the index procedure with usual care in non-STEMI patients with multivessel disease.

Detailed description

Background: Patients with non-ST elevation myocardial infarction (non-STEMI), as compared with STEMI patients, have a higher risk profile, more often MVD and less favourable outcome. Recent studies showed that complete revascularization in STEMI patients is feasible and effective. However, there is no clear evidence regarding the role of complete coronary revascularization by PCI in patients with non-STEMI with MVD. Objective: To compare FFR guided complete revascularization during the index procedure with usual care in non-STEMI patients with multivessel disease. Design: Prospective, multicentre, 1:1 randomized, investigator initiated study. Hypothesis: FFR guided complete percutaneous revascularisation of all significant stenosis in the non-culprit lesion performed within the index PCI procedure will improve clinical outcomes compared to the usual care, guided by discretion of the physician.

Conditions

• Coronary Artery Disease
• NSTEMI - Non-ST Segment Elevation MI
• Fractional Flow Reserve, Myocardial
• Myocardial Revascularization
• Percutaneous Coronary Intervention

Interventions

Type	Name	Description
PROCEDURE	Ischemia driven revascularization	In the ischemia driven complete revascularisation strategy group all flow limiting (FFR ≤ 0.80) lesions will receive treatment by PCI and stenting during the index intervention
OTHER	Usual care group	In the randomised to usual care group the procedure will stop after the PCI of the culprit artery and the patient will be referred to his treating cardiologist and/ or heart team who will decide whether a staged PCI of the non- IRA artery should take place. If the treating cardiologist (after advise of the heart team) decides to perform the non-IRA PCI revascularisation, than such treatment should take place within six weeks from the primary PCI in order to count as a scheduled staged PCI procedure.

Timeline

• Start date: 2018-06-07
• Primary completion: 2025-07-21
• Completion: 2027-07-01
• First posted: 2018-06-19
• Last updated: 2025-08-15

Locations

9 sites across 3 countries: Czechia, Hungary, Netherlands