Status:
NOT_YET_RECRUITING
Microvascular Obstruction Diagnosis Using the CoFI™ System Assessment - II
Lead Sponsor:
CorFlow Therapeutics AG
Conditions:
Microvascular Obstruction (MVO)
STEMI - ST Elevation Myocardial Infarction
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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...
Detailed Description
Microvascular obstruction (MVO) is a common complication that occurs after establishing coronary vessel patency by percutaneous coronary intervention (PCI) for the treatment of acute myocardial infarc...
Eligibility Criteria
Inclusion
- Clinical:
- 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.
- PPCI \& Angiographic
- 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
- Successful PPCI Procedure as documented by \<50% diameter residual angiographic stenosis within all treated culprit lesions with TIMI 2 or 3 flow.
Exclusion
- Clinical:
- 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);
- Any type of non-MRI compatible ear implant;
- Metal shavings in the orbits;
- Any metallic foreign body, shrapnel, or bullet in a location which the physician feels would present a risk to the subject;
- Any history indicating contraindication to MRI
- Inability to follow breath hold instructions or to maintain a breath hold for \>15 seconds; and
- Known hypersensitivity or contraindication to gadolinium contrast.
- 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
- Major bleeding ≤ 30d prior to intervention
- Major surgery ≤ 30d prior to intervention
- TIA or stroke ≤ 30d prior to intervention
- Heart failure with inotrope support and/or consideration for LVAD or heart transplant
- Known severe renal disease with creatinine \> 2.5 mg/dL and/or eGFR \< 30 mL/min/1.73 m2
- 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
- Current participation in another clinical study
- Pregnancy
- PPCI \& Angiographic:
- CABG of LAD
- Unsuitable target vessel anatomy (excessive tortuosity, diffuse disease, or moderate/heavy calcification)
- Cardiac condition preventing the use of the CoFI System
- Any angiographic post stenting condition that according to the physician implies soc administration of any GpIIb/IIIa inhibitors or adenosine
- Cardiac condition mandating elective PCI/CABG procedure prior to CMRI
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06909578
Start Date
September 1 2025
End Date
December 1 2026
Last Update
July 10 2025
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