Assessment of Coronary Artery Disease Before Transcatheter Aortic Valve Replacement: A Randomized, Multicenter, Non-Inferiority Trial

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMedical University Innsbruck

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Standard Invasive Coronary Angiography
  • PCD-CT-Guided Diagnostic Strategy

Treatment groups

700 Participants
are divided into 2 treatment groups

Sponsors and collaborators