CompletedPhase 1

The MOCA I Study - Microvascular Obstruction with CoFI™ System Assessment

Lithuania, Switzerland, United Kingdom73 participantsStarted 2019-06-04

Plain-language summary

First-in-Human study to assess the CoFI™ device related safety and the feasibility of the diagnostic and the therapeutic sequence as well as the correlation between the dynamic microvascular resistance (dMVR) and microvascular obstruction (MVO) as measured by MRI in patients presenting with acute ST-elevation myocardial infarction (STEMI) undergoing percutaneous coronary intervention (PCI).

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Major Inclusion Criteria: * Patients 18 years of age or older presenting with ST-elevation myocardial infarction in the left anterior descending artery (LAD) undergoing primary percutaneous coronary intervention. * Competent mental condition to provide signed and dated ethics committee approved study consent prior to study related procedures * Eligible for prasugrel, ticagrelor, cangrelor, tirofiban, UFH and GP IIb/IIIa inhibitors * Referred for primary PCI within 5 hours of symptom onset with evidence of continuing ischemia and symptom to balloon time not exceeding 6 hours Major Exclusion Criteria: * Unconsciousness * Previous bypass graft surgery * Contraindication to CMRI * Recent or current major bleeding within 30 days prior to intervention * Recent major surgery within 30 days prior to intervention * End-stage heart failure with inotrope support and/or consideration for LVAD or heart transplant * Transient ischemic attack or stroke within 30 days prior to intervention * Pregnant or females of childbearing potential

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The incidence of study device or study procedure adverse effect or event

Timeframe: up to 30 days

Trial details

NCT IDNCT03654573

SponsorCorFlow Therapeutics AG

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-12-18

View on ClinicalTrials.gov More STEMI - ST Elevation Myocardial Infarction trials