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

NCT07107568 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 700

Last updated 2025-08-22

No results posted yet for this study

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)

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.

Sponsors & Collaborators

  • Medical University Innsbruck

    lead OTHER

Principal Investigators

  • Sebastian J Reinstadler, MD, PhD · Medical University of Innsbruck

  • Martin Reindl, MD, PhD · Medical University of Innsbruck

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-14
Primary Completion
2029-12-31
Completion
2029-12-31

Countries

  • Austria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07107568 on ClinicalTrials.gov