June 29, 2020
Interim Data Reported From the First-in-Human MOCA I Trial of CorFlow's CoFI System
June 29, 2020—Switzerland-based CorFlow Therapeutics AG announced that Felice Gragnano, MD, presented interim clinical data from the MOCA I phase 2 clinical trial during the virtual PCR eCourse 2020. The presentation is currently available at the conference website, PCRonline. The MOCA I study is a first-in-human (FIH) clinical trial to document the safety and feasibility of the CorFlow CoFI controlled flow infusion system in patients with acute ST-segment elevation myocardial infarction (STEMI).
The FIH nonrandomized MOCA I study is led by principal investigator Professor Marco Valgimigli, MD, from Inselspital, Bern University Hospital in Bern, Switzerland and Cardiocentro Ticino, Lugano, Switzerland. Dr. Gragnano is also from Inselspital, Bern University Hospital.
Dr. Gragnano highlighted the clinical need for a device that can diagnose microvascular obstruction (MVO) while the STEMI patients are still in the cardiac catheterization lab (CCL). To date, five non-STEMI (NSTEMI) and 13 STEMI patients have been enrolled in phases 1 and 2 of the MOCA trial, respectively. The online PCR presentation documented the findings in the first five 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, noted CorFlow.
According to the company, the 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, there were no device-related deaths, flow-limiting dissections, or thromboembolic events during the procedure and at 30-day follow-up. The presentation also documented a 100% success rate of completing the CoFI diagnostic procedure in the first enrolled patients.
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 10 patients enrolled and analyzed, the second phase documented the correlation between periprocedural dMVR values, measured by the CoFI system, and perfusion parameters quantified by MRI 3 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 CCL. This finding opens the window to diagnose the coronary microcirculation and to monitor treatment effects while the patients are still in the CCL, stated CorFlow.
“The MOCA trial provides fascinating new insights into the coronary microcirculation,” commented Professor Javier Escaned, MD, in the announcement. “A diagnostic method for MVO is a potential breakthrough in identifying STEMI patients with higher risk while they are still in the cath lab and this will also be key in setting the indication of specific treatments for microcirculatory injury.” Prof. Escaned is Head of Interventional Cardiology at Hospital Clinico San Carlos in Madrid, Spain.
The CoFI system diagnostic dMVR technology is designed to differentiate patients with and without MVO after stent implantation in patients with acute STEMI to help cardiologists manage STEMI patients in the CCL without changing the established intervention workflow. In patients with substantial microvascular impairment, the CoFI system also allows for the controlled delivery of intracoronary therapeutic agents and monitoring the treatment effect before the patients leave the CCL.
The CoFI system has received FDA Breakthrough Device designation. An early feasibility study in the United States using the first-generation devices, advised CorFlow.