NCT03654573

Brief 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).

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
73

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jun 2019

Longer than P75 for phase_1

Geographic Reach
3 countries

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 16, 2018

Completed
15 days until next milestone

First Posted

Study publicly available on registry

August 31, 2018

Completed
9 months until next milestone

Study Start

First participant enrolled

June 4, 2019

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 18, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 18, 2024

Completed
Last Updated

March 19, 2025

Status Verified

March 1, 2025

Enrollment Period

5.5 years

First QC Date

August 16, 2018

Last Update Submit

March 17, 2025

Conditions

STEMI - ST Elevation Myocardial InfarctionMicrovascular Obstruction

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Diagnostic Success

    0 days

  • Therapeutic Success

    0 days

Study Arms (1)

STEMI patients

EXPERIMENTAL

Adult subjects presenting with STEMI in the LAD undergoing PPCI

Device: CorFlow Controlled Flow Infusion System - CoFI™

Interventions

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.

STEMI patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

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

Kaunas, 50161, Lithuania

Location

Vilnius University Hospital Santariskiu Klinikos

Vilnius, 08661, Lithuania

Location

Inselspital Bern

Bern, Canton of Bern, Switzerland

Location

Cardiocentro Ticino

Lugano, Canton Ticino, 6900, Switzerland

Location

HUG Geneva

Geneva, Switzerland

Location

CHUV Lausanne

Lausanne, Switzerland

Location

UniversitätsSpital Zürich

Zurich, 8091, Switzerland

Location

Leeds Teaching Hospitals NHS Trust

Leeds, United Kingdom

Location

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Lukas Hunziker

    Insel Gruppe AG, University Hospital Bern

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: N= 50 Diagnostic and N= 20 Therapeutic
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 16, 2018

First Posted

August 31, 2018

Study Start

June 4, 2019

Primary Completion

December 18, 2024

Study Completion

December 18, 2024

Last Updated

March 19, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)LI(2)CH(5)