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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
73
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.
The Hospital of Lithuanian University of Health Sciences (LSMU) Kauno klinikos
Kaunas, Lithuania
Vilnius University Hospital Santariskiu Klinikos
Vilnius, Lithuania
Inselspital Bern
Bern, Canton of Bern, Switzerland
Cardiocentro Ticino
Lugano, Canton Ticino, Switzerland
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).
Time frame: up to 30 days
Diagnostic Success
Ability to perform a diagnostic sequence and to calculate a base flow resistance curve
Time frame: 0 days
Therapeutic Success
Ability to perform the therapeutic sequence as described in the CIP
Time frame: 0 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
HUG Geneva
Geneva, Switzerland
CHUV Lausanne
Lausanne, Switzerland
UniversitätsSpital Zürich
Zurich, Switzerland
Leeds Teaching Hospitals NHS Trust
Leeds, United Kingdom