Clinical Trial

Microvascular Obstruction Diagnosis Using the CoFI™ System Assessment - II

Study acronym: MOCA II
Not Yet Recruiting
View on ClinicalTrials.gov →
Summary
A prospective, multicenter, international single-arm, pivotal clinical study designed to validate the performance of the CoFI system in detecting MVO in STEMI subjects, as confirmed by CMRI. The study will be conducted in accordance with the Declaration of Helsinki, EN ISO 14155:2020, local and national regulations. Each study site will receive support from a sponsor-certified proctor during the learning curve to ensure consistent and accurate application of the CoFI system.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-03-27.
Trial Details
NCT Number NCT06909578
Lead Sponsor CorFlow Therapeutics AG
Conditions Microvascular Obstruction (MVO), STEMI - ST Elevation Myocardial Infarction
Enrollment 200 participants
Start Date 2025-09-01
Primary Completion 2026-12-01 (estimated)
Study Completion 2026-12-01 (estimated)
Updated on ClinicalTrials.gov 2025-07-10