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Recruiting NCT07107568

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

No phase Interventional Aortic Valve Stenosis and Insufficiency Coronary Artery Disease(CAD) Transcatheter Aortic Valve Replacement (TAVR)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Standard Invasive Coronary Angiography, PCD-CT-Guided Diagnostic Strategy.
Who it may be relevant to
Registry conditions: Aortic Valve Stenosis and Insufficiency, Coronary Artery Disease(CAD), Transcatheter Aortic Valve Replacement (TAVR). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Austria
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Detailed description

The goal of this randomized, multicenter trial is to assess the safety and efficacy of a non-invasive diagnostic strategy using photon-counting detector computed tomography (PCD-CT) for the assessment of coronary artery disease (CAD) prior to transcatheter aortic valve replacement (TAVR), compared to the current standard of care using invasive coronary angiography (ICA).

The trial evaluates the hypothesis that a PCD-CT-guided strategy is non-inferior to routine ICA with respect to the risk of major adverse cardiovascular events (MACE) at 12 months. MACE is defined as a composite of all-cause mortality, nonfatal myocardial infarction, nonfatal stroke, urgent revascularization, or bleeding.

Interventions

  • Diagnostic test Standard Invasive Coronary Angiography
    Standard invasive coronary angiography performed routinely for all participants in this arm to assess coronary artery disease before TAVR.
  • Diagnostic test 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.

Primary outcome measures

  • Major adverse cardiovascular events (MACE) at 12 months [Time frame: 12 months after randomization]
Secondary outcome measures (6)
  • All-cause mortality at 12 months [Time frame: 12 months after randomization]
  • Cardiovascular mortality at 12 months [Time frame: 12 months after randomization]
  • Nonfatal myocardial infarction at 12 months [Time frame: 12 months after randomization]
  • Nonfatal stroke at 12 months [Time frame: 12 months after randomization]
  • Urgent revascularization at 12 months [Time frame: 12 months after randomization]
  • Bleeding events at 12 months [Time frame: 12 months after randomization]

Eligibility criteria

Inclusion criteria

  • 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 criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Diagnostic

Study locations

Austria · 1 center
  • Medical University of Innsbruck — Innsbruck

Identifiers

NCT: NCT07107568 · 1124/2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗