Phase 2Not yet recruiting
Randomised EValuation of Therapies for microvAscuLar Injury in STEACS (REVITALISE)
- Sponsor
- CorFlow Therapeutics AG (Industry)
- Enrollment
- 250 planned
- Conditions
- STEMI (ST Elevation MI)
- Interventions
- Therapeutic sequence; Diagnostic sequence
- Ages
- adults, older adults
- Registry
- NCT06935383
Full record on ClinicalTrials.gov
From the registry
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).
Primary outcomes
- Delta LVEF at post procedure and 6 months follow up visit
History
Primary completion expected
Started
Registered