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Assessment of Coronary Artery Disease Before Transcatheter Aortic Valve Replacement: A Randomized, Multicenter, Non-Inferiority Trial
Sponsor: Medical University Innsbruck
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
700
Start Date
2025-08-14
Completion Date
2029-12-31
Last Updated
2025-08-22
Healthy Volunteers
No
Conditions
Interventions
Standard Invasive Coronary Angiography
Standard invasive coronary angiography performed routinely for all participants in this arm to assess coronary artery disease before TAVR.
PCD-CT-Guided Diagnostic Strategy
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)
Medical University of Innsbruck
Innsbruck, Austria