About this trial
The clinical and demographic characteristics of patients undergoing transcatheter aortic valve implantation (TAVI) pose unique challenges for coronary computed tomography (CT) imaging, as this patient population is mainly composed of elderly, frail individuals with severe aortic stenosis, multiple comorbidities, high prevalence of heavily calcified coronary artery disease (CAD) and revascularized coronary arteries. Such vulnerable patients could benefit from a more precise assessment and characterization of their CAD with ultra-high resolution (UHR) photon-counting detector (PCD) CT that would potentially avoid the need for pre-implantation invasive coronary angiography (ICA). This international multicenter prospective registry study aims to investigate the feasibility and diagnostic accuracy of PCD-CT in the assessment of CAD in the high-risk population of patients undergoing TAVI, as compared to ICA.
Eligibility criteria
Qualifiers
Clinically indicated TAVI
Clinically indicated CT and invasive coronary angiography
There are no contraindications to CT angiography.
Understanding and signing the consent form
Disqualifiers
Pregnancy or breastfeeding
Chronic renal failure (eGFR <30 ml/m2)
Active oncological treatment
Any condition for which TAVI is contraindicated and therefore no prior radiological investigation of TAVI is indicated
Trial design
Treatments tested in this trial
- Ultra-High Resolution Photon Counting Detector Coronary Computed Tomography Angiography
Treatment groups
Sponsors and collaborators
Semmelweis University
Lead sponsor
Siemens Corporation, Corporate Technology
Collaborator