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

Primary Purpose

STEMI - ST Elevation Myocardial Infarction, Microvascular Obstruction

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
CorFlow Controlled Flow Infusion System - CoFI™
Sponsored by
CorFlow Therapeutics AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for STEMI - ST Elevation Myocardial Infarction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Hospital of Lithuanian University of Health Sciences (LSMU) Kauno klinikos
  • Vilnius University Hospital Santariskiu Klinikos
  • Cardiocentro TicinoRecruiting
  • Inselspital BernRecruiting
  • HUG GenevaRecruiting
  • CHUV Lausanne
  • UniversitätsSpital Zürich

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

STEMI patients

Arm Description

Adult subjects presenting with STEMI in the LAD undergoing PPCI

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Diagnostic Success
Ability to perform a diagnostic sequence and to calculate a base flow resistance curve
Therapeutic Success
Ability to perform the therapeutic sequence as described in the CIP

Full Information

First Posted
August 16, 2018
Last Updated
February 10, 2022
Sponsor
CorFlow Therapeutics AG
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1. Study Identification

Unique Protocol Identification Number
NCT03654573
Brief Title
The MOCA I Study - Microvascular Obstruction With CoFI™ System Assessment
Acronym
MOCA
Official Title
The MOCA I Study - Microvascular Obstruction With CoFI™ System Assessment
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 4, 2019 (Actual)
Primary Completion Date
July 2022 (Anticipated)
Study Completion Date
September 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CorFlow Therapeutics AG

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
STEMI - ST Elevation Myocardial Infarction, Microvascular Obstruction

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
N= 50 Diagnostic and N= 20 Therapeutic
Masking
None (Open Label)
Allocation
N/A
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
STEMI patients
Arm Type
Experimental
Arm Description
Adult subjects presenting with STEMI in the LAD undergoing PPCI
Intervention Type
Device
Intervention Name(s)
CorFlow Controlled Flow Infusion System - CoFI™
Intervention Description
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 Measure Information:
Title
The incidence of study device or study procedure adverse effect or event
Description
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).
Time Frame
up to 30 days
Secondary Outcome Measure Information:
Title
Diagnostic Success
Description
Ability to perform a diagnostic sequence and to calculate a base flow resistance curve
Time Frame
0 days
Title
Therapeutic Success
Description
Ability to perform the therapeutic sequence as described in the CIP
Time Frame
0 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Giovanna Catalano
Phone
+41 79 690 69 20
Email
gcatalano@corflow-therapeutics.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lukas Hunziker
Organizational Affiliation
Insel Gruppe AG, University Hospital Bern
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Hospital of Lithuanian University of Health Sciences (LSMU) Kauno klinikos
City
Kaunas
ZIP/Postal Code
50161
Country
Lithuania
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ramunas Unikas, Prof. Dr.
Facility Name
Vilnius University Hospital Santariskiu Klinikos
City
Vilnius
ZIP/Postal Code
08661
Country
Lithuania
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arvydas Baranauskas, Dr.
Facility Name
Cardiocentro Ticino
City
Lugano
State/Province
TI
ZIP/Postal Code
6900
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marco Moccetti, Dr.
First Name & Middle Initial & Last Name & Degree
Marco Moccetti, Dr.
Facility Name
Inselspital Bern
City
Bern
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lukas Hunziker, Prof. Dr.
First Name & Middle Initial & Last Name & Degree
Lukas Hunziker, Prof. Dr.
Facility Name
HUG Geneva
City
Geneva
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juan F. Iglesias, Dr
First Name & Middle Initial & Last Name & Degree
Juan F. Iglesias, Dr.
Facility Name
CHUV Lausanne
City
Lausanne
Country
Switzerland
Individual Site Status
Active, not recruiting
Facility Name
UniversitätsSpital Zürich
City
Zürich
ZIP/Postal Code
8091
Country
Switzerland
Individual Site Status
Active, not recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

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

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