RecruitingNot ApplicableNCT07107568

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

Sponsor

Medical University Innsbruck

Enrollment

700 participants

Start Date

Aug 14, 2025

Study Type

INTERVENTIONAL

Conditions

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

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying PCD-CT-Guided Diagnostic Strategy and Standard Invasive Coronary Angiography for people with aortic valve stenosis and insufficiency, coronary artery disease (cad), and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTStandard Invasive Coronary Angiography

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

DIAGNOSTIC_TESTPCD-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.