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Trial record 1 of 1 for:    "MOCA I"
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The MOCA I Study - Microvascular Obstruction With CoFI™ System Assessment (MOCA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03654573
Recruitment Status : Recruiting
First Posted : August 31, 2018
Last Update Posted : April 24, 2020
Sponsor:
Information provided by (Responsible Party):
CorFlow Therapeutics AG

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).

Condition or disease Intervention/treatment Phase
STEMI - ST Elevation Myocardial Infarction Microvascular Obstruction Device: CorFlow Controlled Flow Infusion System - CoFI™ Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: N= 20 Diagnostic and N= 20 Therapeutic
Masking: None (Open Label)
Primary Purpose: Other
Official Title: The MOCA I Study - Microvascular Obstruction With CoFI™ System Assessment
Actual Study Start Date : June 4, 2019
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

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.




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03654573


Contacts
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Contact: Esther Gerteis +41 41 544 55 56 egerteis@corflow-therapeutics.ch

Locations
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Switzerland
Inselspital Bern Recruiting
Bern, Switzerland
Contact: Marco Valgimigli, Prof. Dr.         
Principal Investigator: Marco Valgimigli, Prof. Dr.         
HUG Geneva Recruiting
Geneva, Switzerland
Contact: Juan F. Iglesias, Dr         
Principal Investigator: Juan F. Iglesias, Dr.         
CHUV Lausanne Recruiting
Lausanne, Switzerland
Contact: Stephane Fournier, Dr.         
Principal Investigator: Stephane Fournier, Dr.         
Sponsors and Collaborators
CorFlow Therapeutics AG
Investigators
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Study Director: Esther Gerteis CorFlow Therapeutics AG
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Responsible Party: CorFlow Therapeutics AG
ClinicalTrials.gov Identifier: NCT03654573    
Other Study ID Numbers: 1801
First Posted: August 31, 2018    Key Record Dates
Last Update Posted: April 24, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Myocardial Infarction
ST Elevation Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases