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.

CompletedOBSERVATIONAL
Enrollment

450

Participants

Timeline

Start Date

August 6, 2020

Primary Completion Date

September 30, 2022

Study Completion Date

May 31, 2023

Conditions
Stable Ischemic Heart DiseaseCoronary Artery Disease
Interventions
PROCEDURE

CCTA (Coronary Computed Tomography Angiography)

Per the protocol, patients had a coronary computed tomography angiography within standard of care before the enrollment to the study.

PROCEDURE

ICA (Invasive Coronary Angiography)

Per the protocol, patients will have an Invasive Coronary Angiography within standard of care.

PROCEDURE

FFR (Fractional Flow Reserve)

Per the protocol, patients will have a Fractional Flow Reserve procedure within standard of care.

DEVICE

CNBP measurement

Per the protocol, patients will have the measurement of the resting Continuous Non-Invasive Blood Pressure (CNBP). The signal is required for iSIL-FFR technology.

DEVICE

Cardiolens FFR-CT Pro

Per the protocol, non-invasive FFR measurements will be perfomed via Cardiolens FFR-CT Pro technology for the enrolled patients.

Trial Locations (11)

43-316

American Heart of Poland, Centrum Kardiologii i Kardiochirurgii w Bielsku-Białej, Bielsko-Biala

Unknown

The University Clinical Centre, Gdansk

The Leszek Giec Upper-Silesian Medical Centre of the Silesian Medical University, Katowice

The Cardinal Stefan Wyszyński National Institute of Cardiology, Warsaw

The 4th Military Teaching Hospital, Wroclaw

The Jan Mikulicz-Radecki University Teaching Hospital, Wroclaw

The T. Marciniak Lower Silesian Specialist Hospital - Center of Emergency Medicine, Wroclaw

30-688

Oddział Kliniczny Kardiologii oraz Interwencji Sercowo-Naczyniowych Szpital Uniwersytecki w Krakowie, Krakow

31-202

The John Paul II Specialist Hospital in Cracovia, Krakow

59-301

"Miedziowe Centrum Zdrowia S.A.", Lubin

43-450

American Heart of Poland, Centrum Sercowo - Naczyniowe w Ustroniu, Ustroń

All Listed Sponsors
collaborator

GENELYTICA Sp. z o.o.

UNKNOWN

lead

Hemolens Diagnostics Sp. z o.o.

OTHER

NCT04777513 - 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. | Biotech Hunter | Biotech Hunter