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NCT07472634
Evaluation of the Performance of the Cardiolens® Platform, Which Utilizes a Non-Invasive Combined Anatomical and Functional CCTA-based Assessment in Patients With Suspected CCS
trial testing CCTA (Coronary Computed Tomography Angiography) in Chronic Coronary Syndrome in 150 participants. Completed in 4 July 2025.
26 June 2025
Quick facts
| Lead sponsor | Hemolens Diagnostics Sp. z o.o. |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 150 |
| Start date | 18 October 2023 |
| Primary completion | 26 June 2025 |
| Estimated completion | 4 July 2025 |
| Sites | 8 locations across Poland |
Drugs / interventions tested
- CCTA (Coronary Computed Tomography Angiography)
- ICA (Invasive Coronary Angiography)
- FFR (Fractional Flow Reserve)
- CNBP measurement
- Cardiolens Platform
Conditions studied
- Chronic Coronary Syndrome — all drugs for Chronic Coronary Syndrome →
Sponsor
Hemolens Diagnostics Sp. z o.o.
Who can join
Adults 18 to 90, any sex, with Chronic Coronary Syndrome. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
A prospective, confirmatory, multicenter, open-label clinical investigation of a Class IIa medical device (in accordance with Article 62 of Regulation 2017/745), conducted to confirm the performance of the Cardiolens® Platform, which is based on a non-invasive, combined anatomical and functional assessment (intention-to-diagnose) using CCTA in patients with suspected chronic coronary syndrome (CCS). The introduction of the new diagnostic method - the Cardiolens® Platform - will benefit enrolled patients by reducing the number of diagnostic procedures, including invasive procedures, that currently provide equivalent diagnostic information for the identification of significant coronary stenoses qualifying for prognostic revascularization (i.e., those causing large areas of ischemia). Virtual simulations and results generated by the Cardiolens® Platform will be compared with reference data from standard procedures performed in each participant and with actual clinical decisions made based on routine diagnostic methods. Therefore, no control group has been deemed necessary for this study. Additionally, simulations related to the assessment (results) of FFRCT and MBF-CT obtained using the Cardiolens® Platform will be blinded with respect to participant data and randomly assigned to investigators for final evaluation of ischemia significance.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT07472634
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of CCTA (Coronary Computed Tomography Angiography)
Trials testing the same drug.
- NCT04777513 — Evaluation of Diagnostic Accuracy, Safety, and Cost-Effectiveness of the Non-Invasive Cardiolens FFR-CT Pro Method to Me · completed
Other recruiting trials for Chronic Coronary Syndrome
Currently open trials in the same condition.
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Other Hemolens Diagnostics Sp. z o.o. trials
Trials by the same sponsor.
- NCT04777513 — Evaluation of Diagnostic Accuracy, Safety, and Cost-Effectiveness of the Non-Invasive Cardiolens FFR-CT Pro Method to Me · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07472634 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Hemolens Diagnostics Sp. z o.o.
- Last refreshed: 18 March 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07472634.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing