Microvascular Obstruction Diagnosis Using the CoFI™ System Assessment - II

Launched by CORFLOW THERAPEUTICS AG · Mar 27, 2025

Keywords

ClinConnect Summary

This clinical trial, titled "Microvascular Obstruction Diagnosis Using the CoFI™ System Assessment - II," is designed to test a new system called the CoFI system, which helps detect a condition known as microvascular obstruction (MVO) in patients experiencing a type of heart attack called STEMI (ST Elevation Myocardial Infarction). The goal is to see how well this system works compared to a specialized imaging technique called cardiac MRI (CMRI). The trial will take place across multiple locations and will ensure that trained experts assist with the process to guarantee accurate results.

To participate in this trial, individuals must be at least 18 years old and have been diagnosed with an acute anterior STEMI, meaning their heart is currently experiencing a serious blockage. They should have persistent symptoms for less than six hours. However, certain conditions may exclude someone from participating, such as recent major surgery, severe heart problems, or pregnancy. Those who join the study can expect to have their heart health monitored closely, and they will be contributing to important research that could improve future heart attack treatments.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• * Clinical:
• • 1. Subject ≥18 years of age
• • 2. Ability to provide written informed consent according to GCP and governing regulations
• • 3. Diagnosis of acute anterior STEMI
• • 4. 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.
• • PPCI \& Angiographic
• • 1. Culprit lesion in the LAD
• • 2. COFI ballon can be placed according to IFU
• • 3. Required stent diameter ≥ 2.75 mm and ≤ 5mm
• • 4. Required stent length ≥ 15 mm
• • 5. Successful PPCI Procedure as documented by \<50% diameter residual angiographic stenosis within all treated culprit lesions with TIMI 2 or 3 flow.
• Exclusion Criteria:
• * Clinical:
• • 1. Cardiogenic shock
• • 2. Thrombolytic therapy administered for this STEMI
• • 3. Contraindication to CMRI
• • 1. Cardiac pacemaker or implantable defibrillator;
• • 2. Non-MRI compatible aneurysm clip;
• • 3. Neural Stimulator (i.e., TENS unit);
• • 4. Any implanted or magnetically activated device (insulin pump);
• • 5. Any type of non-MRI compatible ear implant;
• • 6. Metal shavings in the orbits;
• • 7. Any metallic foreign body, shrapnel, or bullet in a location which the physician feels would present a risk to the subject;
• • 8. Any history indicating contraindication to MRI
• • 9. Inability to follow breath hold instructions or to maintain a breath hold for \>15 seconds; and
• • 10. Known hypersensitivity or contraindication to gadolinium contrast.
• • 4. Subject with previous MI and/or known cardiomyopathy (ischemic and non ischemic), ventricular pseudoaneurysm, VSD, severe mitral valve regurgitation (with or without papillary muscle rupture), severe known cardiac valvular stenosis or insufficiency, pericardial disease
• • 5. Major bleeding ≤ 30d prior to intervention
• • 6. Major surgery ≤ 30d prior to intervention
• • 7. TIA or stroke ≤ 30d prior to intervention
• • 8. Heart failure with inotrope support and/or consideration for LVAD or heart transplant
• • 9. Known severe renal disease with creatinine \> 2.5 mg/dL and/or eGFR \< 30 mL/min/1.73 m2
• • 10. Subject has other medical illness (e.g., cancer, dementia) or known history of substance abuse (alcohol, cocaine, heroin, etc.) that may cause non-compliance with the CIP, confound the data interpretation, or is associated with limited life expectancy of less than one year
• • 11. Current participation in another clinical study
• • 12. Pregnancy
• PPCI \& Angiographic:
• • 1. CABG of LAD
• • 2. Unsuitable target vessel anatomy (excessive tortuosity, diffuse disease, or moderate/heavy calcification)
• • 3. Cardiac condition preventing the use of the CoFI System
• • 4. Any angiographic post stenting condition that according to the physician implies soc administration of any GpIIb/IIIa inhibitors or adenosine
• • 5. Cardiac condition mandating elective PCI/CABG procedure prior to CMRI