Randomised EValuation of Therapies for microvAscuLar Injury in STEACS
ConditionSTEMI (ST Elevation MI)
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCorFlow Therapeutics AG
About this trial
The goal of this interventional study is to evaluate if the CoFI system can act as a platform for intracoronary infusion of therapeutic agents to treat and relieve microvascular injury in ST Elevation Acute Coronary Syndrome (ACS) subjects diagnosed with MicroVascular Obstruction (MVO) after Primary Percutaneous Intervention (PPCI) and to quantify (identify) markers of treatment efficacy for CoFI mediated therapeutic agents infusion versus control.
The targeted population is subjects presenting with an ST elevation myocardial infarction and undergoing PPCI as per standard of care.
Enrolled STEMI subjects will be examined for MVO with the CoFI system. Primary endpoint of the study is EF by TTE at 6 months.
If detected with MVO with the CoFI system, the subjects will be randomized and will receive treatment with medicinal product(s).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Subjects age ≥18 years old
Ability to provide informed assent/consent to the study according to GCP, governing regulations and approved process
Infarct-related lesion in proximal or mid left anterior descending coronary artery
ECG evidence of acute anterior myocardial infarction with ST-elevation ≥ 2 mm (0.2 mV) in 2 or more contiguous anterior precordial ECG leads (one of which should be V2, V3, or V4) in men or ≥ 1.5 mm (0.15 mV) in women
Disqualifiers
Unconscious on presentation
Patients under judicial protection, legal guardianship or curatorship
Mental disorder or language barrier that precludes informed assent/consent GCP, governing regulations and approved process
Known severe kidney disease (estimated glomerular filtration rate (eGFR) < 30 ml/min) or on haemodialysis
Trial design
Design model
Parallel
Treatments tested in this trial
Therapeutic sequence
Devicethe required dose of treatment is administered through the CoFI system
Diagnostic sequence
DeviceDiagnostic sequence to detect MVO
Treatment groups
250 Participants
are divided into 3 treatment groupsGroup A: ShameSham comparator 1 intervention
Group B: Treatment AExperimental treatment 2 interventions
Group C: Treatment BExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Delta LVEF at post procedure and 6 months follow up visit
Absolute difference in left ventricular ejection fraction (LVEF) measured within 24 hours post-primary percutaneous coronary intervention (PPCI) and 6 months follow up, using transthoracic echocardiography (TTE) assessed blind to treatment group assignment.
Time frame
From enrollment to the 6 months follow up visitLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: