# 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.

> **NCT04777513** · — · COMPLETED · sponsor: **Hemolens Diagnostics Sp. z o.o.** · enrollment: 450 (actual)

## Conditions studied

- Stable Ischemic Heart Disease
- Coronary Artery Disease

## Interventions

- **PROCEDURE:** CCTA (Coronary Computed Tomography Angiography)
- **PROCEDURE:** ICA (Invasive Coronary Angiography)
- **PROCEDURE:** FFR (Fractional Flow Reserve)
- **DEVICE:** CNBP measurement
- **DEVICE:** Cardiolens FFR-CT Pro

## Key facts

- **NCT ID:** NCT04777513
- **Lead sponsor:** Hemolens Diagnostics Sp. z o.o.
- **Sponsor class:** OTHER
- **Phase:** —
- **Study type:** OBSERVATIONAL
- **Status:** COMPLETED
- **Start date:** 2020-08-06
- **Primary completion:** 2022-09-30
- **Final completion:** 2023-05-31
- **Target enrollment:** 450 (ACTUAL)
- **Last updated:** 2024-05-16

## Collaborators

- [object Object]

## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT04777513

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration 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.". Retrieved via AI Analytics 2026-06-08 from https://api.ai-analytics.org/clinical/NCT04777513. Licensed CC0.

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