Assessment of Coronary Artery Disease Before Transcatheter Aortic Valve Replacement: A Randomized, Multicenter, Non-Inferiority Trial
Medical University Innsbruck
700 participants
Aug 14, 2025
INTERVENTIONAL
Conditions
Summary
The goal of this clinical trial is to determine whether a non-invasive coronary assessment strategy using photon-counting detector computed tomography (PCD-CT) is non-inferior to invasive coronary angiography (ICA) for evaluating coronary artery disease (CAD) prior to transcatheter aortic valve replacement (TAVR) in patients with severe aortic stenosis.
Eligibility
Inclusion Criteria4
- Age ≥ 18 years
- Severe aortic valve stenosis and indication for intervention according to current European Society of Cardiology (ESC) guidelines
- TAVR candidate
- Written informed consent
Exclusion Criteria4
- Cardiogenic shock at presentation (e.g., emergency indication for TAVR)
- Severe renal impairment with an estimated glomerular filtration rate of <30 mL/min/1.73 m²
- Life expectancy <1 year due to other severe non-cardiac disease (e.g., malignancy)
- Pregnancy
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Interventions
Standard invasive coronary angiography performed routinely for all participants in this arm to assess coronary artery disease before TAVR.
Participants randomized to this arm will undergo coronary artery disease (CAD) assessment using photon-counting detector computed tomography (PCD-CT). Invasive coronary angiography (ICA) will only be performed if PCD-CT shows significant CAD, defined as ≥70% diameter stenosis in vessels ≥2.5 mm or ≥50% in the left main artery.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07107568