The MOCA I Study - Microvascular Obstruction with CoFI™ System Assessment
NCT ID: NCT03654573
Last Updated: 2025-03-19
Study Results
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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COMPLETED
PHASE1
73 participants
INTERVENTIONAL
2019-06-04
2024-12-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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STEMI patients
Adult subjects presenting with STEMI in the LAD undergoing PPCI
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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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CorFlow Therapeutics AG
INDUSTRY
Responsible Party
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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
Vilnius University Hospital Santariskiu Klinikos
Vilnius, , Lithuania
Inselspital Bern
Bern, Canton of Bern, Switzerland
Cardiocentro Ticino
Lugano, Canton Ticino, Switzerland
HUG Geneva
Geneva, , Switzerland
CHUV Lausanne
Lausanne, , Switzerland
UniversitätsSpital Zürich
Zurich, , Switzerland
Leeds Teaching Hospitals NHS Trust
Leeds, , United Kingdom
Countries
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Other Identifiers
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1801
Identifier Type: -
Identifier Source: org_study_id
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