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

NCT07107568 | Recruiting DMC

• 1 other identifier: 1124/2025
• Study Type: interventional
• Target: 700
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Aortic Valve Stenosis and Insufficiency; Coronary Artery Disease(CAD); Transcatheter Aortic Valve Replacement (TAVR)

Keywords

TAVR-CT; PCD-CT; Severe Aortic Stenosis; Transcatheter Aortic Valve Replacement; TAVR; Photon-Counting Detector CT; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• 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 events. All events will be adjudicated by an independent, blinded clinical events committee.

  12 months after randomization

Secondary Outcomes (6)

• All-cause mortality at 12 months

  12 months after randomization

• Cardiovascular mortality at 12 months

  12 months after randomization

• Nonfatal myocardial infarction at 12 months

  12 months after randomization

• Nonfatal stroke at 12 months

  12 months after randomization

• Urgent revascularization at 12 months

  12 months after randomization

Study Arms (2)

PCD-CT-Guided Diagnostic Strategy

EXPERIMENTAL

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.

Diagnostic Test: PCD-CT-Guided Diagnostic Strategy

Standard Invasive Coronary Angiography

ACTIVE COMPARATOR

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.

Diagnostic Test: Standard Invasive Coronary Angiography

Interventions

Standard Invasive Coronary Angiography DIAGNOSTIC_TEST

Standard invasive coronary angiography performed routinely for all participants in this arm to assess coronary artery disease before TAVR.

Standard Invasive Coronary Angiography

PCD-CT-Guided Diagnostic Strategy DIAGNOSTIC_TEST

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University Innsbruck: lead

Study Sites (1)

Medical University of Innsbruck

Innsbruck, 6020, Austria

RECRUITING

MeSH Terms

Conditions

Aortic Valve Stenosis; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction; Coronary Disease; Myocardial Ischemia; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Sebastian J Reinstadler, MD, PhD

  Medical University of Innsbruck

  PRINCIPAL INVESTIGATOR

• Martin Reindl, MD, PhD

  Medical University of Innsbruck

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sebastian J Reinstadler, MD, PhD

CONTACT

+43 512 504 25665; sebastian.reinstadler@tirol-kliniken.at

Ivan Lechner, MD, PhD

CONTACT

+43 512 504 25665; ivan.lechner@tirol-kliniken.at

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: An independent, blinded Clinical Events Committee will adjudicate all primary and key secondary endpoints based on medical records. The committee members will not be informed of the participants' group allocation (PCD-CT vs. ICA). The statistical analysis will also be conducted by an independent statistician blinded to treatment assignment.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, controlled, multicenter, open-label, parallel-group, two-arm non-inferiority trial. Participants are assigned in a 1:1 ratio to either a PCD-CT-guided diagnostic strategy or standard invasive coronary angiography prior to TAVR evaluation.

Study Record Dates

• First Submitted: July 28, 2025
• First Posted: August 6, 2025
• Study Start: August 14, 2025
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: August 22, 2025

Record last verified: 2025-07

Locations

AU (1)