Assessment of Coronary Artery Disease Before Transcatheter Aortic Valve Replacement: A Randomized, Multicenter, Non-Inferiority Trial
Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Austria
Medical University of Innsbruck
RECRUITING
Innsbruck
Contact Information
Primary
Sebastian J Reinstadler, MD, PhD
sebastian.reinstadler@tirol-kliniken.at
+43 512 504 25665
Backup
Ivan Lechner, MD, PhD
ivan.lechner@tirol-kliniken.at
+43 512 504 25665
Time Frame
Start Date: 2025-08-14
Estimated Completion Date: 2029-12-31
Participants
Target number of participants: 700
Treatments
Experimental: 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.
Active_comparator: Standard Invasive Coronary Angiography
Participants randomized to this arm will undergo routine invasive coronary angiography (ICA) as the standard of care for pre-TAVR assessment of coronary artery disease.
Related Therapeutic Areas
Sponsors
Leads: Medical University Innsbruck