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

STEMI - ST Elevation Myocardial Infarction Clinical Trial

— MOCA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03654573
• Other study ID #: 1801
• Status: Recruiting
• Phase: N/A
• Start date: June 4, 2019
• Est. completion date: June 30, 2024

Study information

• Verified date: December 2023
• Source: CorFlow Therapeutics AG
• Contact: Giovanna Catalano
• Phone: +41 79 690 69 20
• Email: gcatalano[@]corflow-therapeutics.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: June 30, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Infarction
• Microvascular Obstruction
• Myocardial Infarction
• ST Elevation Myocardial Infarction
• STEMI - ST Elevation Myocardial Infarction

Intervention

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.

Locations

Country	Name	City	State
Lithuania	The Hospital of Lithuanian University of Health Sciences (LSMU) Kauno klinikos	Kaunas
Lithuania	Vilnius University Hospital Santariskiu Klinikos	Vilnius
Switzerland	Inselspital Bern	Bern
Switzerland	HUG Geneva	Geneva
Switzerland	CHUV Lausanne	Lausanne
Switzerland	Cardiocentro Ticino	Lugano	TI
Switzerland	UniversitätsSpital Zürich	Zürich

Sponsors (1)

Lead Sponsor	Collaborator
CorFlow Therapeutics AG

Countries where clinical trial is conducted

Lithuania,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Diagnostic Success	Ability to perform a diagnostic sequence and to calculate a base flow resistance curve	0 days
Secondary	Therapeutic Success	Ability to perform the therapeutic sequence as described in the CIP	0 days