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

Study Overview
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Brief Summary
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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).

Official Title
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The MOCA I Study - Microvascular Obstruction With CoFI™ System Assessment

Conditions
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Microvascular Obstruction, STEMI - ST Elevation Myocardial Infarction

Intervention / Treatment
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* Device: CorFlow Controlled Flow Infusion System - CoFI™


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: N= 50 Diagnostic and N= 20 Therapeutic
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: STEMI patients<br>Adult subjects presenting with STEMI in the LAD undergoing PPCI | Device: CorFlow Controlled Flow Infusion System - CoFI™<br>* The CorFlow CoFI™ System is intended to assess the dynamic microvascular resistance and to treat microvascular obstruction in the coronary vasculature of patients following PCI with stent placement.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of study device or study procedure adverse effect or event | Safety Objective is the incidence of study device or study procedure adverse effect or event at up to 30 days. 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 primary percutaneous coronary intervention (PPCI). | up to 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic Success | Ability to perform a diagnostic sequence and to calculate a base flow resistance curve | 0 days | 
| Therapeutic Success | Ability to perform the therapeutic sequence as described in the CIP | 0 days |