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

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).

Study Overview

• Status: Completed
• Conditions: STEMI - ST Elevation Myocardial Infarction; Microvascular Obstruction
• Intervention / Treatment: Device: CorFlow Controlled Flow Infusion System - CoFI™

• Study Type: Interventional
• Enrollment (Actual): 73
• Phase: Phase 1

Contacts and Locations

Study Locations

• Lithuania
  • Kaunas, Lithuania, 50161
    • The Hospital of Lithuanian University of Health Sciences (LSMU) Kauno klinikos
  • Vilnius, Lithuania, 08661
    • Vilnius University Hospital Santariskiu Klinikos
• Switzerland
  • Bern, Switzerland
    • Inselspital Bern
  • Geneva, Switzerland
    • HUG Geneva
  • Lausanne, Switzerland
    • CHUV Lausanne
  • Zürich, Switzerland, 8091
    • Universitatsspital Zurich
  • TI
    • Lugano, TI, Switzerland, 6900
      • Cardiocentro Ticino
• United Kingdom
  • Leeds, United Kingdom
    • Leeds Teaching Hospitals NHS Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: STEMI patients; Adult subjects presenting with STEMI in the LAD undergoing PPCI	Device: CorFlow Controlled Flow Infusion System - CoFI™; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence of study device or study procedure adverse effect or event	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).	up to 30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic Success	Ability to perform a diagnostic sequence and to calculate a base flow resistance curve	0 days
Therapeutic Success	Ability to perform the therapeutic sequence as described in the CIP	0 days

Collaborators and Investigators

• Sponsor: CorFlow Therapeutics AG
• Investigators: Principal Investigator: Lukas Hunziker, Insel Gruppe AG, University Hospital Bern

Study record dates

Study Major Dates

• Study Start (Actual): June 4, 2019
• Primary Completion (Actual): December 18, 2024
• Study Completion (Actual): December 18, 2024

Study Registration Dates

• First Submitted: August 16, 2018
• First Submitted That Met QC Criteria: August 30, 2018
• First Posted (Actual): August 31, 2018

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 17, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Necrosis; Myocardial Ischemia; Ischemia; ST Elevation Myocardial Infarction; Myocardial Infarction; Infarction
• Other Study ID Numbers: 1801

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No