At the end of June 2020, Dr. Felice Gragnano, MD, Inselspital, University Hospital of Bern, Bern, Switzerland presented preliminary clinical data from MOCA I Phase 2 clinical trials during the PCR e-Course. The MOCA I study is the first clinical trial in humans (FIH) to document the safety and feasibility of the CorFlow Controlled Flow Infusion (CoFI ™) Infusion System in patients with acute heart attacks (STEMI).
During his presentation, Dr. Gragnano highlighted the clinical need for a tool that can diagnose microvascular obstruction (MVO) while STEMI patients are still in the cathlab. To date, 5 non-STEMI patients (NSTEMI) and 13 STEMI have been enrolled in Phases 1 and 2 of the MOCA trial, respectively. The presentation documented the findings in 5 NSTEMI patients and 10 first STEMI. Data from these first 15 patients have been 100% verified and all side effects are decided by an independent clinical event committee.
Safety data from the first 15 patients indicate that the CoFI ™ diagnostic procedure is safe and no device-related adverse events occurred in one of the study participants. In particular, no device-related deaths, surgery that restricted flow, or thromboembolic events were found during the procedure as well as at 30-day follow-up. The presentation also documented a 100% success rate in completing the CoFI ™ diagnostic procedure in patients who were first registered.
The MOCA I study is a non-randomized three-phase FIH clinical trial and the Main Investigator is Prof. Marco Valgimigli, MD, PhD, Inselspital, Bern University Hospital, Bern / Cardiocentro Ticino, Lugano, Switzerland. Phase 2 of the MOCA I study documented the ability of the CoFI ™ system to measure exclusive proprietary CorFlow Dynamic Microvascular Resistance (dMVR) parameters in 20 STEMI patients. With the first ten patients enrolled and analyzed, this phase has documented a correlation between periprocedural dMVR values, measured by the CoFI ™ System, and perfusion parameters measured by magnetic resonance imaging (MRI) three days after the revascularization procedure.
Data from the first 10 STEMI patients also show that the CoFI ™ diagnostic procedure can distinguish patients with or without MVO at the cathlab. This finding opens a window for diagnosing coronary microcirculation and monitoring the effects of treatment while the patient is still in cathlab.
Prof. Javier Escaned, Head of Interventional Cardiology at Clinico San Carlos Hospital, Madrid, Spain, commented: “The MOCA trial provides interesting new insights into coronary microcirculation. The diagnostic method for MVO is a potential breakthrough in identifying STEMI patients with a higher risk when they are still at cathlab and this will also be key in establishing specific care indications for microcirculation injuries. “
CoFI ™ system dMVR diagnostic technology (COF cost) is designed to distinguish patients with and without MVO after stent implantation in patients with acute myocardial infarction (STEMI). This will potentially help the cardiologist to better manage STEMI patients in the catheter laboratory (“cathlab”) without changing the workflow of the established intervention. In patients with substantial microvascular disorders, the CoFI ™ system also allows for controlled delivery of intra-coronary therapeutic agents and monitors the effects of treatment before patients leave the cathlab.
The CoFI ™ system has received the US Food and Drug Administration (FDA) Breakthrough Device Designation and CorFlow is planning an Early Feasibility Study (EFS) in the US using a first generation device.
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