Skip to main content
OpenTrials
Completed

NCT Number: NCT03654573

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

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

STEMI - ST Elevation Myocardial Infarction Cardiovascular Diseases Heart Diseases Infarction Ischemia Microvascular Obstruction Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms ST Elevation Myocardial Infarction Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The Hospital of Lithuanian University of Health Sciences (LSMU) Kauno klinikos, Kaunas, Lithuania

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CorFlow Controlled Flow Infusion System - CoFI™

Device

The CorFlow CoFI™ System is intended to assess the dynamic microvascular resistance and to treat microvascular obstruction in the coronary vasculature of patients following PCI with stent placement.

Primary outcomes

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

    Time frame: up to 30 days

    Safety Objective is the incidence of study device or study procedure adverse effect or event at up to 30 days. 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 primary percutaneous coronary intervention (PPCI).

Secondary outcomes

  1. Diagnostic Success

    Time frame: 0 days

    Ability to perform a diagnostic sequence and to calculate a base flow resistance curve

  2. Therapeutic Success

    Time frame: 0 days

    Ability to perform the therapeutic sequence as described in the CIP

Sponsors and collaborators

Lead sponsor

CorFlow Therapeutics AG

Industry

Registry information

Acronym: MOCA

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Aug 31, 2018
Registry last updated
Mar 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.