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.

Summary

A multicentre, post-marketing, observational trial in 450 patients, whose standard diagnostic workup for chronic coronary syndromes provided for Invasive Coronary Angiography (ICA). Medical records of a potential subject of the trial before their enrolment contain a good quality result of at least 128-slice CCTA performed up to 3 months before the elective ICA. CCTA should find at least one ≥50% stenosis in at least one big coronary artery of ≥ 2 mm diameter. At one hour before ICA in the latest the patient should have a resting Continuous Non-Invasive Blood Pressure (CNBP) taken with a certified device delivered by LifeFlow. The last criterion before including a patient in the final analysis is at least one significant (≥50%) stenosis in one or two coronary arteries of ≥ 2 mm diameter visually confirmed by ICA with a FFR measurement taken in these arteries.

The data collection period will cover time from admission for the elective ICA to discharge from the hospital (evaluation of possible adverse events related to invasive procedures).

After initial qualification of available data by the attending physician, selected patients will be asked for a consent to participation in the trial no later than upon admission for the elective ICA and before CNBP measurement.

Conditions

• Stable Ischemic Heart Disease
• Coronary 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.

Sponsors & Collaborators

• GENELYTICA Sp. z o.o.

  collaborator UNKNOWN

• Hemolens Diagnostics Sp. z o.o.

  lead OTHER

Principal Investigators

• Cezary Kępka, MD, PhD · The National Institute of Cardiology

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-08-06

Primary Completion

2022-09-30

Completion

2023-05-31

FDA Device

Yes

Countries

• Poland

Study Locations