Using photon-counting CT instead of invasive angiography to check coronary arteries before TAVR
Assessment of Coronary Artery Disease Before Transcatheter Aortic Valve Replacement: A Randomized, Multicenter, Non-Inferiority Trial
This test will see if a newer photon-counting CT scan (PCD-CT) can safely replace invasive coronary angiography to look for coronary artery disease in adults having TAVR for severe aortic stenosis.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 700 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Medical University Innsbruck Academic / other |
| Locations | 1 site (Innsbruck) |
| Trial ID | NCT07107568 on ClinicalTrials.gov |
What this trial studies
This randomized, multicenter non-inferiority trial compares a non-invasive PCD-CT-guided diagnostic strategy to routine invasive coronary angiography (ICA) before transcatheter aortic valve replacement (TAVR). Participants eligible for TAVR are randomized to either PCD-CT-directed management or standard ICA, with treatment decisions made based on the assigned imaging strategy. The primary outcome is major adverse cardiovascular events (MACE) at 12 months, a composite including all-cause death, nonfatal myocardial infarction, nonfatal stroke, urgent revascularization, or bleeding. Key exclusions include cardiogenic shock, severe renal impairment (eGFR <30 mL/min/1.73 m²), pregnancy, or life expectancy under one year.
Who should consider this trial
Good fit: Adults with severe aortic stenosis who are candidates for TAVR, able to provide informed consent, and without severe renal failure, cardiogenic shock, or other life-limiting non-cardiac disease are appropriate candidates.
Not a fit: Patients in cardiogenic shock, those requiring emergency TAVR, people with severe renal impairment (eGFR <30 mL/min/1.73 m²), pregnant patients, or those with life expectancy under one year are unlikely to benefit from this non-invasive strategy.
Why it matters
Potential benefit: If successful, patients could avoid an invasive angiogram and its risks by using a non-invasive PCD-CT approach while keeping similar safety for heart-related events.
How similar studies have performed: Conventional CT coronary angiography has shown promise as a non-invasive option in selected TAVR populations, but photon-counting detector CT is newer and this randomized non-inferiority trial is among the first rigorous tests of that technology.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Innsbruck
- Medical University of Innsbruck — Innsbruck, Austria (Recruiting)
Study contacts
- Principal investigator: Sebastian J Reinstadler, MD, PhD — Medical University Innsbruck
- Study coordinator: Sebastian J Reinstadler, MD, PhD
- Email: sebastian.reinstadler@tirol-kliniken.at
- Phone: +43 512 504 25665
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.