First Patients Enrolled into the MOCA I Trialadmin
First Patients Enrolled into the MOCA I Trial
Baar, Switzerland, June 25th 2019
CorFlow Therapeutics AG (“CorFlow”) today announced that the first two patients have been enrolled into the First-in-Man (FIM) MOCA I clinical trial.
The first MOCA (Microvascular Obstruction with the CoFITM System Assessment) trial is a safety and feasibility trial assessing the CorFlow Controlled Flow Infusion (CoFITM) System. In the first roll-in phase, non-acute (NSTEMI) patients will undergo microvascular obstruction (MVO) diagnosis using CorFlow’s proprietary dynamic Microvascular Resistance (dMVR) sequence. In phase II, dMVR will be measured in acute (STEMI) patients and the peri-procedural measurements will be correlated with post-procedure magnetic resonance imaging (MRI) which will be assessed by an independent MRI corelab. Finally, in Phase III, STEMI patients will be diagnosed using dMVR measurements and treated using intra-coronary CoFITM delivery of tirofiban followed by a final diagnostic sequence. Tirofiban is a small molecule antiplatelet drug belonging to a class of antiplatelet drugs named glycoprotein IIb/IIIa inhibitors. dMVR measurements will again be correlated with post-procedure MRI and evaluated by the independent corelab.
MVO is an independent marker for heart failure and death following acute heart attack (STEMI). An effective MVO diagnostic method and treatment has the potential to markedly reduce late complications following heart attack.
Two patients diagnosed with NSTEMI, underwent standard coronary stenting at the University Hospital of Bern (Inselspital), Switzerland. After successful stent placements, the CorFlow Rapid Exchange CoFITM Catheter was delivered to the stent to measure distal myocardial microvascular resistance. All measurements were successfully completed, without any clinical impact, in less than 2 minutes of coronary artery occlusion during the diagnostic CoFITM sequence. The patients were discharged from Inselspital with no complications.
Prof. Marco Valgimigli, the Principal Investigator of the MOCA I trial, commented: “The CoFI diagnostic sequence is simple and feasible in non-acute heart attack patients. I’m pleased that the system fits our cath lab work flow which will be important when we enter the second phase of the MOCA trial enrolling acute heart attack patients.”
The diagnostic CoFITM sequence precisely infuses a crystalloid solution into the coronary microcirculation at a series of flow values. These flows are similar to or lower than resting coronary flow, thus avoiding any non-physiological hemodynamics in the coronary circulation. During the flow infusion, the resulting pressure measurements, using the Opsens OptoWire, enables dMVR assessment quickly and simply. In preclinical studies, the dMVR correlates well with Microvascular Obstruction (MVO) as measured by MRI post procedure.
CorFlow therefore believes that dMVR measurements will be an important diagnostic tool for MVO assessment in real-time during interventional catheter laboratory (cath lab) procedures. This will enable MVO therapy by agent infusion into the microcirculation.
Jon H. Hoem, CorFlow’s CEO and co-Founder, said: “We are very proud to reach this important milestone three years after we founded the company. This progress was made possible by an enormous effort by the CorFlow team, the close cooperation with our investigators, the trusted support from our investors and with the consent of the patients included into the MOCA trial. We look forward to enrolling the remaining patients in the trial.”
The MOCA I study will assess important data on the feasibility of detecting, quantifying and treating MVO in acute heart attack patients. Data from this trial will be used for further product development, the CorFlow world-wide regulatory activities and will build the base for further clinical trials.
The MOCA I study is funded by CorFlow and through a public grant which the company has been awarded from Innosuisse, the Swiss Innovation Agency.
The MOCA I Study Summary
The CorFlow First-in-Man MOCA I study is designed to study the safety and feasibility of the Controlled Flow Infusion (CoFI™) Technology. In total the study will investigate up to 58 NSTEMI and STEMI patients using the diagnostic and therapeutic components of the CoFI™ System.
The primary safety objective of the study is to investigate the incidence of device or procedure adverse effects or events inside 30 days post procedure. Furthermore, the study will assess the CoFI™ device safety and feasibility of the diagnostic and the therapeutic sequence as well as the correlation between the dynamic Microvascular Resistance (dMVR) and microvascular obstruction as quantified by MRI in patients presenting with acute ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PPCI).
The major inclusion criteria for the study are:
- 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.
For further information on the MOCA I clinical trial please refer to the registration of the study in clinicaltrials.gov.