The MOCA I Study - Microvascular Obstruction with CoFI™ System Assessment

CorFlow Therapeutics

Status and phase

Completed

Phase 1

Conditions

Microvascular Obstruction

STEMI - ST Elevation Myocardial Infarction

Treatments

Device: CorFlow Controlled Flow Infusion System - CoFI™

Study type

Interventional

Funder types

Industry

Identifiers

NCT03654573

1801

Details and patient eligibility

About

First-in-Human study to assess the CoFI™ device related safety and the feasibility of the diagnostic and the therapeutic sequence as well as the correlation between the dynamic microvascular resistance (dMVR) and microvascular obstruction (MVO) as measured by MRI in patients presenting with acute ST-elevation myocardial infarction (STEMI) undergoing percutaneous coronary intervention (PCI).

Enrollment

73 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Major Inclusion Criteria:

Patients 18 years of age or older presenting with ST-elevation myocardial infarction in the left anterior descending artery (LAD) undergoing primary percutaneous coronary intervention.
Competent mental condition to provide signed and dated ethics committee approved study consent prior to study related procedures
Eligible for prasugrel, ticagrelor, cangrelor, tirofiban, UFH and GP IIb/IIIa inhibitors
Referred for primary PCI within 5 hours of symptom onset with evidence of continuing ischemia and symptom to balloon time not exceeding 6 hours

Major Exclusion Criteria:

Unconsciousness
Previous bypass graft surgery
Contraindication to CMRI
Recent or current major bleeding within 30 days prior to intervention
Recent major surgery within 30 days prior to intervention
End-stage heart failure with inotrope support and/or consideration for LVAD or heart transplant
Transient ischemic attack or stroke within 30 days prior to intervention
Pregnant or females of childbearing potential