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

NCT ID: NCT03654573

Last Updated: 2025-03-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

73 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-04

Study Completion Date

2024-12-18

Brief Summary

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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).

Detailed Description

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Conditions

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STEMI - ST Elevation Myocardial Infarction Microvascular Obstruction

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

N= 50 Diagnostic and N= 20 Therapeutic
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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STEMI patients

Adult subjects presenting with STEMI in the LAD undergoing PPCI

Group Type EXPERIMENTAL

CorFlow Controlled Flow Infusion System - CoFI™

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CorFlow Therapeutics AG

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lukas Hunziker

Role: PRINCIPAL_INVESTIGATOR

Insel Gruppe AG, University Hospital Bern

Locations

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

Kaunas, , Lithuania

Site Status

Vilnius University Hospital Santariskiu Klinikos

Vilnius, , Lithuania

Site Status

Inselspital Bern

Bern, Canton of Bern, Switzerland

Site Status

Cardiocentro Ticino

Lugano, Canton Ticino, Switzerland

Site Status

HUG Geneva

Geneva, , Switzerland

Site Status

CHUV Lausanne

Lausanne, , Switzerland

Site Status

UniversitätsSpital Zürich

Zurich, , Switzerland

Site Status

Leeds Teaching Hospitals NHS Trust

Leeds, , United Kingdom

Site Status

Countries

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Lithuania Switzerland United Kingdom

Other Identifiers

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1801

Identifier Type: -

Identifier Source: org_study_id

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