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Clinical trial

Evaluation of Diagnostic Accuracy, Safety, and Cost-Effectiveness of the Non-Invasive Cardiolens FFR-CT Pro Method to Measure the Fractional Flow Reserve in Diagnostics of Chronic Coronary Syndromes Versus the Standard Diagnostic Modalities. A Multicentre Post-marketing Trial of a Class 2a Medical Device, Cardiolens FFR-CT Pro - Software for Non-invasive Determination of Haemodynamic Parameters in Coronary Arteries.

NCT04777513 is registered in ClinicalTrials.gov with Hemolens Diagnostics Sp. z o.o. as lead sponsor.

NCT NCT04777513
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Registry record

As filed in ClinicalTrials.gov.

Title
Evaluation of Diagnostic Accuracy, Safety, and Cost-Effectiveness of the Non-Invasive Cardiolens FFR-CT Pro Method to Measure the Fractional Flow Reserve in Diagnostics of Chronic Coronary Syndromes Versus the Standard Diagnostic Modalities. A Multicentre Post-marketing Trial of a Class 2a Medical Device, Cardiolens FFR-CT Pro - Software for Non-invasive Determination of Haemodynamic Parameters in Coronary Arteries.
Lead sponsor
Hemolens Diagnostics Sp. z o.o.
Phase
Observational
Overall status
Completed
Start date
August 6, 2020
Completion date
May 31, 2023
Enrollment
450 (actual)
Sites
11

Conditions

As the registry lists them; a condition with its own page is linked.

coronary artery disease, stable ischemic heart disease