Assessment of Coronary Artery Disease Before Transcatheter Aortic Valve Replacement: A Randomized, Multicenter, Non-Inferiority Trial
NCT ID: NCT07107568
Last Updated: 2025-08-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
700 participants
INTERVENTIONAL
2025-08-14
2029-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
SINGLE
Study Groups
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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.
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.
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.
Standard Invasive Coronary Angiography
Standard invasive coronary angiography performed routinely for all participants in this arm to assess coronary artery disease before TAVR.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Severe aortic valve stenosis and indication for intervention according to current European Society of Cardiology (ESC) guidelines
* TAVR candidate
* Written informed consent
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Medical University Innsbruck
OTHER
Responsible Party
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Principal Investigators
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Sebastian J Reinstadler, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Medical University of Innsbruck
Martin Reindl, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Medical University of Innsbruck
Locations
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Medical University of Innsbruck
Innsbruck, , Austria
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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1124/2025
Identifier Type: -
Identifier Source: org_study_id
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