NCT06935383

Randomised EValuation of Therapies for microvAscuLar Injury in STEACS

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 250 (estimated)
• Sponsor: CorFlow Therapeutics AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• STEMI (ST Elevation MI)

Interventions

Type	Name	Description
DEVICE	Therapeutic sequence	the required dose of treatment is administered through the CoFI system
DEVICE	Diagnostic sequence	Diagnostic sequence to detect MVO

Timeline

• Start date: 2025-09-01
• Primary completion: 2027-09-01
• Completion: 2027-09-01
• First posted: 2025-04-20
• Last updated: 2025-04-20