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

Last updated: March 17, 2025
Sponsor: CorFlow Therapeutics AG
Overall Status: Completed

Phase

1

Condition

Coronary Artery Disease

Heart Defect

Circulation Disorders

Treatment

CorFlow Controlled Flow Infusion System - CoFI™

Clinical Study ID

NCT03654573
1801
  • Ages > 18
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Major Inclusion Criteria:

  • Patients 18 years of age or older presenting with ST-elevation myocardial infarctionin the left anterior descending artery (LAD) undergoing primary percutaneouscoronary intervention.

  • Competent mental condition to provide signed and dated ethics committee approvedstudy consent prior to study related procedures

  • Eligible for prasugrel, ticagrelor, cangrelor, tirofiban, UFH and GP IIb/IIIainhibitors

  • Referred for primary PCI within 5 hours of symptom onset with evidence of continuingischemia and symptom to balloon time not exceeding 6 hours

Exclusion

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 hearttransplant

  • Transient ischemic attack or stroke within 30 days prior to intervention

  • Pregnant or females of childbearing potential

Study Design

Total Participants: 73
Treatment Group(s): 1
Primary Treatment: CorFlow Controlled Flow Infusion System - CoFI™
Phase: 1
Study Start date:
June 04, 2019
Estimated Completion Date:
December 18, 2024

Connect with a study center

  • The Hospital of Lithuanian University of Health Sciences (LSMU) Kauno klinikos

    Kaunas, 50161
    Lithuania

    Site Not Available

  • Vilnius University Hospital Santariskiu Klinikos

    Vilnius, 08661
    Lithuania

    Site Not Available

  • Cardiocentro Ticino

    Lugano, TI 6900
    Switzerland

    Site Not Available

  • Inselspital Bern

    Bern,
    Switzerland

    Site Not Available

  • HUG Geneva

    Geneva,
    Switzerland

    Site Not Available

  • CHUV Lausanne

    Lausanne,
    Switzerland

    Site Not Available

  • UniversitätsSpital Zürich

    Zürich, 8091
    Switzerland

    Site Not Available

  • Leeds Teaching Hospitals NHS Trust

    Leeds,
    United Kingdom

    Site Not Available

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