Heart/Cardiovascular Diseases UCLA Clinical Trial | Microvascular Obstruction Diagnosis Using the CoFI™ System Assessment - II | UCLA Health Clinical Trials and Research Studies

About

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 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.

Primary Purpose

Diagnostic

Study Type

Interventional

Phase

Phase 3/Phase 4

Eligibility

Gender

All

Healthy Volunteers

No

Minimum Age

18 Years

Maximum Age

N/A

Inclusion Criteria:

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 Criteria:

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

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