Microvascular Obstruction Diagnosis Using the CoFIâ„¢ System Assessment - II (NCT06909578) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Microvascular Obstruction Diagnosis Using the CoFIâ„¢ System Assessment - II
200 participantsStarted 2025-09-01
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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.
✓. Culprit lesion in the LAD
✓. COFI ballon can be placed according to IFU
✓. Required stent diameter ≥ 2.75 mm and ≤ 5mm
✓. Required stent length ≥ 15 mm
Exclusion criteria
✕. Cardiogenic shock
✕. Thrombolytic therapy administered for this STEMI
✕. Contraindication to CMRI
✕. Cardiac pacemaker or implantable defibrillator;
✕. Non-MRI compatible aneurysm clip;
✕. Neural Stimulator (i.e., TENS unit);
✕. Any implanted or magnetically activated device (insulin pump);
What they're measuring
1
Primary Effectiveness Endpoint
Timeframe: From enrollment to the end of treatment at 6 Months