Completado

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.

0 criterios cumplidosConsulta de un vistazo cómo tu perfil cumple con cada criterio de elegibilidad.
Qué se está recopilando

Colección de datos

Recopilados desde hoy en adelante - Prospectivo
Quiénes están siendo reclutados

Enfermedades Oclusivas Arteriales+4

+ Enfermedad de las arterias coronarias

+ Arteriosclerosis

A partir de 18 años
Ver todos los criterios de elegibilidad
Cómo está diseñado el estudio

Solo Casos

Examinando las características de las personas con una enfermedad para identificar factores genéticos o ambientales que contribuyen a la condición.
Observacional
Inicio del estudio: agosto de 2020
Ver detalles del protocolo

Resumen

Patrocinador PrincipalHemolens Diagnostics Sp. z o.o.
Última actualización: 28 de enero de 2026
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Fecha de inicio: 6 de agosto de 2020

Fecha en la que se inscribió al primer participante.

Stage 1 After a patient declares their consent, a doctor or another member of the study team trained by the sponsor will perform procedures in the following order: * Define the unique patient ID to be recorded in the CRF with the patient's demographic data * Assess the quality of CCTA imaging data (DICOM) according to guidelines agreed upon with the sponsor and record the number and location of the significant (≥50%) stenosis sites in the CRF based on CCTA * No later than one hour before ICA starts, perform a physical examination consisting in instantaneous peripheral blood pressure (systolic and diastolic) resting measurement performed with a standard sphygmomanometer and Continuous Non-Invasive Blood Pressure measurement (1-3 min). Stage 2 After the procedures mentioned above are performed, the patient will undergo elective ICA with the outcomes, i.e.: * video material showing the location of the wire during the FFR measurement, * digital pressure signals exported from the FFR measuring device used to determine the value of the invasive FFR, * values of FFR measurements obtained during ICA will be entered after being anonymised in a dedicated HEMOFLOW PMS\_2020 reference database. Stage 3 Within 48 hours of ICA completion a doctor or another member of the study team trained by the sponsor: * will enter the following data in the Cardiolens FFR-CT Pro system: 1. Patient's data, i.e. patient's ID, gender, height, body mass, exercise tolerability, information on used medications and smoking cigarettes. Optionally, i.e. if upon admission for ICA a blood test was performed as a part of the standard diagnostic workup - haematocrit levels and total protein concentration 2. Files containing CCTA imaging data in the DICOM format. 3. Values of instantaneous peripheral blood pressure (systolic and diastolic) resting measurement performed with a standard sphygmomanometer as well as the digital signal obtained during the CNBP measurement (1-3 min) * Based on the CCTA description or meta data contained in the imaging data the doctor or another member of the study team will record the following information in the CRF: 1. Radiation dose during CCTA 2. Contrast medium dose during CCTA * Will enter the following information in the CRF: 1. Radiation dose during the diagnostic part of ICA 2. Contrast medium dose during the diagnostic part of ICA 3. Number and type of adverse events 4. Duration of the diagnostic workup. Stage 4 Within 7 days of entering all the stage 3 data the investigator (a cardiologist) trained by the sponsor will measure the value of the virtual FFR with the Cardiolens FFR-CT Pro system at locations corresponding to ICA FFR measurements (based on video recording entered in the database during stage 2) Based on results obtained from the Cardiolens FFR-CT Pro system vs reference data an analysis will be performed on meeting the primary and secondary end points of the trial.

Título OficialEvaluation 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
Patrocinador PrincipalHemolens Diagnostics Sp. z o.o.
Última actualización: 28 de enero de 2026
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Protocolo

Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.
Detalles del Diseño

Se reclutarán 450 pacientes

Número total de participantes que el ensayo clínico espera reclutar.

Solo Casos

Estos estudios se centran únicamente en personas con una enfermedad específica. Se analizan patrones, frecuentemente genéticos o ambientales, para identificar posibles factores relacionados con la condición.

Elegibilidad

Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.
Condiciones
Criterios

Cualquier sexo

Sexo biológico de los participantes elegibles para inscribirse.

A partir de 18 años

Rango de edades de los participantes que pueden unirse al estudio.

Voluntarios sanos no permitidos

Indica si personas sanas, sin la condición que se estudia, pueden participar.

Condiciones

Patología

Enfermedades Oclusivas ArterialesEnfermedad de las arterias coronariasArteriosclerosisEnfermedades CardiovascularesEnfermedades del CorazónEnfermedad CoronariaEnfermedades Vasculares

Criterios

Inclusion Criteria: 1. Age ≥ 18 2. Declaration of informed consent to sharing medical records gathered during the standard diagnostic workup 3. History of chronic coronary syndromes (CCS) 4. Diagnostic CCTA (good quality test allowing investigation of the entire coronary artery tree), showing at least one site with stenosis ≥50% of the lumen in a large coronary artery of ≥ 2 mm diameter, with no prior revascularisation 5. Standard treatment of chronic coronary syndromes with no dosage modification required within at least 4 weeks before the enrolment 6. Patients with a prior acute coronary syndrome (ACS) or revascularisation would be found eligible under the following conditions: * Over 30 days from the acute coronary syndrome occurrence * FFR assessment during ICA may only cover the vessels that were not revascularized (both PCI and CABG) and were not the reason of ACS * No closed coronary arteries Exclusion Criteria: 1. CCTA-confirmed myocardial bridges causing \>50% stenosis of the epicardial vascular lumen 2. Coronary obstruction confirmed by CCTA or invasive coronarography 3. History of ACS with coronary angioplasty or Coronary Artery Bypass Grafting (CABG) performed unless point 6 conditions are met 4. Significant haemodynamic abnormalities of the valve or history of surgical correction of the defect or CABG 5. Second-degree or third-degree atrioventricular block, sinus node dysfunction, QTc \> 450 ms or prolonged QTc 6. LVEF ≤ 35% found in an echocardiogram performed within the last 6 months 7. BMI ≥ 35 8. Clinically apparent infection 9. Thrombocytopenia below 100.000/mm3 10. Active neoplastic disease (apart from basal cell carcinoma and carcinoma in situ) and other conditions, which, in the investigator's opinion significantly affect their life expectancy 11. Other significant conditions, infections, addictions and psychological or social factors, which, in the doctor's opinion, may affect patient's ability to participate in the trial or significantly affect their safety

Plan de Estudio

Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.
Objetivos del Estudio

Objetivos del Estudio

Objetivos Primarios

Objetivos Secundarios

Centros del Estudio

Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.

Este estudio tiene 11 ubicaciones

Suspendido

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

Bielsko-Biala, PolandAbrir American Heart of Poland, Centrum Kardiologii i Kardiochirurgii w Bielsku-Białej en Google Maps
Suspendido

The University Clinical Centre

Gdansk, Poland
Suspendido

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

Katowice, Poland
Suspendido

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

Krakow, Poland
Completado11 Centros de Estudio