FFR Driven Complete Revascularization Versus Usual Care in NSTEMI Patients and Multivessel Disease
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Coronary (Artery) Disease
- Fractional Flow Reserve, Myocardial
- Myocardial Revascularization
- NSTEMI - Non-ST Segment Elevation MI
- Percutaneous Coronary Intervention
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: It concerns an investigator initiated prospective 1:1 randomised clinical trial in non-STEMI patients with multivessel coronary artery disease amenable to treatment with PCI.Masking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 85 years
- Gender
- Both males and females
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 ...
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.
Tracking Information
- NCT #
- NCT03562572
- Collaborators
- Maastricht University Medical Center
- Radboud University
- Jeroen Bosch Ziekenhuis
- VieCuri Medical Centre
- Gottsegen György Országos Kardiológiai Intézet
- Bács-Kiskun County Teaching Hospital
- Investigators
- Principal Investigator: Saman Rasoul, Dr. Zuyderland MC Study Director: Arnoud van 't Hof, Prof. Dr. Zuyderland MC
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