The MOCA-I Study Assessment of microvascular vessel occlusion with the CoFI™ system

Résumé de l'étude

The CorFlow CoFITM System (CorFlow Controlled-Flow Infusion System) is used after the initial treatment of a heart attack via stent implantation and serves to assess (examine) the blood flow (resistance) of the smallest and microvessels of the heart and to treat them if necessary. The international MOCA-I study is being conducted in Belgium, Germany, the United Kingdom, and Switzerland. There is only one study center in Switzerland, the Inselspital Bern. The investigational product is not approved in Europe - it is a first application in humans. Additionally, in the third phase of the study, a drug will be used that is already approved for intravenous use, but not for direct application in the blood vessels of the heart (intracoronary). However, the intracoronary administration of the drug is already routinely used in emergency situations. A total of 40 patients are to be included across Europe.

(BASEC)

Intervention étudiée

The CoFI™ System consists of the CoFI™ RX catheter and the CoFI™ console (data processing and display). With this system, the occlusions of the smallest and microblood vessels of the heart are to be examined and treated. In the MOCA-I study, the safety and feasibility of this examination and treatment are evaluated.

After a routine stent implantation (introduction of a small metal tube that keeps the coronary artery open), an examination of the blood flow of the smallest and microvessels is to be performed. This is done with a special catheter (CoFI™ RX catheter), which measures the pressure differences in the blood vessel and calculates the vascular resistance, which is then displayed on the CoFI™ console. For this purpose, the catheter temporarily occludes the blood vessel at the site of the original occlusion (in the stent) and a physiological saline solution is continuously and controlled administered via the catheter. Through this controlled fluid administration and the residual pressure in the blood vessel, the vascular resistance can be calculated.

This resistance is intended to provide insight into whether the smallest or microvessels of the affected coronary artery are also occluded and need to be treated. The examination lasts only a few minutes.

Afterward, in the third phase of the study, a drug (Aggrastat®) will be used that is already routinely administered as an infusion for these conditions and also locally in the blood vessels of the heart (intracoronary) in emergency situations. This type of application (intracoronary) is not yet approved. With the new catheter, this drug can be evenly and controlled administered into the blood vessel to be treated. This is done in three short cycles of about 1 minute each. The new catheter occludes the blood vessel at the site of the original occlusion (in the stent) to deliver the drug specifically to the smallest and microblood vessels. Afterward, a new examination of the vascular resistance is performed (as previously described). The examinations and treatment cycles together take less than 30 minutes.

Through this examination, it is hoped that in the future, even during the initial treatment (stent implantation), a diagnosis and treatment of any vessel occlusions in the smallest and microvessels can be made, thus avoiding late complications of a heart attack.

(BASEC)

Maladie en cours d'investigation

In an acute heart attack, there is an occlusion of the coronary arteries, which leads to a disturbance of blood flow in the heart muscle. As therapy, the narrowed coronary artery is usually reopened with a stent (small metal tube). However, in addition to the occlusions of the coronary arteries, there can also be occlusions of the subsequent smallest and microvessels of the heart. These cannot be detected with conventional techniques during stent implantation. In the MOCA I study, these smallest and microvessel occlusions are examined and treated. All individuals aged 18 years and older who are suffering from an acute heart attack (occlusion of a coronary artery) that is to be treated with a stent may participate. Pregnant women or individuals participating in another study with an unapproved product or drug may not participate.

(BASEC)

Sponsor

CorFlow Therapeutics AG, Baar

(BASEC)

Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)

Commission cantonale d'éthique de Berne

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Date d'approbation du comité d'éthique

07.05.2019

(BASEC)

Résultats de l'essai