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NOT YET RECRUITING
NCT06909578
NA

Microvascular Obstruction Diagnosis Using the CoFI™ System Assessment - II

Sponsor: CorFlow Therapeutics AG

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

200

Start Date

2025-09-01

Completion Date

2026-12-01

Last Updated

2025-07-10

Healthy Volunteers

No

Interventions

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.