Swiss Authorities Approve the MOCA I Clinical Trialadmin
Swiss Authorities Approve the MOCA I Clinical Trial
Baar, Switzerland, May 9th 2019
CorFlow Therapeutics AG (“CorFlow”) today announced that the Swiss competent authority, Swissmedic, and the Swiss ethics committee, Swissethics, have approved the company’s MOCA I study, which is a three phased First-in-Man clinical trial.
The first MOCA (Microvascular Obstruction with the CoFITM System Assessment) trial is a multi-center prospective, non-randomized safety and feasibility clinical trial which will assess the CorFlow Controlled Flow Infusion (CoFITM) System in up to 58 heart attack patients. In the first roll-in phase, up to 18 non-acute (NSTEMI) patients will undergo microvascular obstruction (MVO) diagnosis using CorFlow’s dynamic Microvascular Resistance (dMVR) sequence. In phase II, dMVR will be measured in 20 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, 20 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. Again, the dMVR measurements will be correlated with post-procedure MRI and evaluated by the independent corelab.
The MOCA I study will generate important information on the feasibility of detecting, quantifying and treating MVO in acute heart attack patients. CorFlow believes that the study will provide early signs on how controlled infusion of intra-coronary agents can reduce the amount of MVO. Microvascular obstruction has been proven in several larger clinical trials to be an independent predictor for major adverse cardiac events such as heart failure and death.
Esther Gerteis, CorFlow’s VP Medical Affairs, commented: “The MOCA I study is the first study which combines diagnosis and treatment of MVO in acute heart attack patients. We look forward to work with the investigators to gain new insights into this unsolved issue. The ultimate goal for the CorFlow clinical activity is to establish a new approach to diagnose and treat MVO in acute heart attack patients whilst following the PCI workflow.”
The first hospital to start enrolling patients will be the University Hospital in Bern (Inselspital) with Prof. Marco Valgimigli as Primary Investigator. Additional sites will start subsequently. The study is funded by CorFlow and through a public grant which the company has been awarded from Innosuisse, the Swiss Innovation Agency.
The CoFITM System is designed to measure the amount of MVO and to treat it while the heart attack patient is still in the catheter laboratory. Furthermore, the proprietary CoFITM System is the only of its kind to combine both MVO diagnosis and therapy while adhering to the current guidelines and workflow for heart attack patients.
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.