Microvascular Obstruction, STEMI - ST Elevation Myocardial Infarction
Conditions
Brief summary
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).
Interventions
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.
Sponsors
CorFlow Therapeutics AG
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
N= 50 Diagnostic and N= 20 Therapeutic
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of study device or study procedure adverse effect or event | up to 30 days | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic Success | 0 days | Ability to perform a diagnostic sequence and to calculate a base flow resistance curve |
| Therapeutic Success | 0 days | Ability to perform the therapeutic sequence as described in the CIP |
Countries
Lithuania, Switzerland, United Kingdom
Outcome results
None listed