Microvascular Obstruction Diagnosis Using the CoFI™ System Assessment - II
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCorFlow Therapeutics AG
About this trial
A prospective, multicenter, international single-arm, pivotal clinical study designed to validate the performance of the CoFI system in detecting MVO in STEMI subjects, as confirmed by CMRI. The study will be conducted in accordance with the Declaration of Helsinki, EN ISO 14155:2020, local and national regulations.
Each study site will receive support from a sponsor-certified proctor during the learning curve to ensure consistent and accurate application of the CoFI system.
Eligibility criteria
Qualifiers
Subject ≥18 years of age
Ability to provide written informed consent according to GCP and governing regulations
Diagnosis of acute anterior STEMI
Persistent symptoms to balloon time ≤ 6 hours. The assessment by the treating investigator after evaluation by subjects explanation is the defining timepoint for symptom onset.
Disqualifiers
Cardiogenic shock
Thrombolytic therapy administered for this STEMI
Contraindication to CMRI
Cardiac pacemaker or implantable defibrillator;
Trial design
Treatments tested in this trial
- CorFlow Controlled Flow Infusion System - CoFI™
Treatment groups
200 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Source ClinicalTrials.gov