Clinical Trial

Randomised EValuation of Therapies for microvAscuLar Injury in STEACS

Study acronym: REVITALISE
Not Yet Recruiting Phase 2
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Summary
The goal of this interventional study is to evaluate if the CoFI system can act as a platform for intracoronary infusion of therapeutic agents to treat and relieve microvascular injury in ST Elevation Acute Coronary Syndrome (ACS) subjects diagnosed with MicroVascular Obstruction (MVO) after Primary Percutaneous Intervention (PPCI) and to quantify (identify) markers of treatment efficacy for CoFI mediated therapeutic agents infusion versus control. The targeted population is subjects presenting with an ST elevation myocardial infarction and undergoing PPCI as per standard of care. Enrolled STEMI subjects will be examined for MVO with the CoFI system. Primary endpoint of the study is EF by TTE at 6 months. If detected with MVO with the CoFI system, the subjects will be randomized and will receive treatment with medicinal product(s).
Trial Details
NCT Number NCT06935383
Lead Sponsor CorFlow Therapeutics AG
Conditions STEMI (ST Elevation MI)
Enrollment 250 participants
Start Date 2025-09
Primary Completion 2027-09 (estimated)
Study Completion 2027-09 (estimated)
Updated on ClinicalTrials.gov 2025-04-20