CorFlow Reports Late-Breaking Data from the “MOCA I” Clinical Trial


In late June 2020, Dr. Felice Gragnano, MD, Inselspital, Bern University Hospital, Bern, Switzerland presented interim clinical data from the MOCA I Phase 2 clinical trial during the PCR e-Course. The MOCA I study is a first-in-human (FIH) clinical trial to document the safety and feasibility of the CorFlow Controlled Flow Infusion (CoFI™) System in patients with acute heart attack (STEMI).

During his presentation, Dr. Gragnano highlighted the clinical need for a device which can diagnose microvascular obstruction (MVO) while the STEMI patients are still in the cathlab. To date 5 non-STEMI (NSTEMI) and 13 STEMI patients have been enrolled in the Phase 1 and 2 of the MOCA trial, respectively. The presentation documented the findings in the first 5 NSTEMI and 10 STEMI patients. The data from these first 15 patients have been 100% source verified and all adverse events were adjudicated by an independent clinical events committee.

The safety data from these first 15 patients show that the CoFI™ diagnostic procedure is safe and no device-related adverse events occurred in any of the study participants. Specifically, no device related deaths, flow-limiting dissections, nor thromboembolic events were found during the procedure as well as at 30-days follow-up. The presentation also documented a 100% success rate of completing the CoFI™ diagnostic procedure in the first enrolled patients.

The MOCA I study is a non-randomized three-phased FIH clinical trial and the Principal Investigator is Prof. Marco Valgimigli, MD, PhD, Inselspital, Bern University Hospital, Bern / Cardiocentro Ticino, Lugano, Switzerland. Phase 2 of the MOCA I study documents the ability of the CoFI™ System to measure the CorFlow proprietary dynamic Microvascular Resistance (dMVR) parameters in 20 STEMI patients. With the first ten patients enrolled and analyzed, this phase has documented the correlation between periprocedural dMVR values, measured by the CoFI™ System, and perfusion parameters quantified 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 differentiate patients with or without MVO in the cathlab. This finding opens the window to diagnose the coronary microcirculation and to monitor treatment effects while the patients are still in the cathlab.

Prof. Javier Escaned, Head of Interventional Cardiology at Hospital Clinico San Carlos, Madrid, Spain, commented: “The MOCA trial provides fascinating new insights into the coronary microcirculation. A diagnostic method for MVO is a potential breakthrough in identifying STEMI patients with higher risk while they are still in the cathlab and this will also be key in setting the indication of specific treatments for microcirculatory injury.”

The CoFI™ (COF-fee) System diagnostic dMVR technology is designed to differentiate patients with and without MVO after stent implantation in patients with acute myocardial infarction (STEMI). This will potentially help cardiologists to better manage STEMI patients in the catheter laboratory (“cathlab”) without changing the established intervention workflow. In patients with substantial microvascular impairment, the CoFI™ System also allows for controlled delivery of intra-coronary therapeutic agents and monitoring the treatment effect before the patients leave the cathlab.

The CoFI™ System has received US Food and Drug Administration (FDA) Breakthrough Device Designation and CorFlow is planning an Early Feasibility Study (EFS) in the US using the first-generation devices.

Cardiology Magazine