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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
CorFlow Controlled Flow Infusion System - CoFI™
DeviceThe CorFlow CoFI™ System is intended to assess the dynamic microvascular resistance and to treat microvascular obstruction in the coronary vasculature of patients following PCI with stent placement.
Treatment groups
200 Participants
are divided into 1 treatment groupGroup A: Adult subjects presenting with STEMI in the LAD undergoing PPCIOther 1 intervention
Trial outcomes
Primary outcomes
1
Primary Effectiveness Endpoint
Diagnostic performance is measured by sensitivity and specificity of the CoFI system in detecting MVO in relation to the pre-set PCoFI threshold of 124 mmHg. The analysis will be per-protocol (PP) (primary) and the full analysis set (FAS) (secondary). Hypothesis Sensitivity and Specificity will be tested to meet the acceptance criteria: i.The lower bound of the confidence interval (CI) for sensitivity is 70% ii. The lower bound of the CI for specificity is 65% H0: p \< p0 H1: p ≥ p0 p0 = 70%se, 65%sp
Time frame
From enrollment to the end of treatment at 6 MonthsLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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