Using photon-counting CT instead of invasive angiography to check coronary arteries before TAVR
Official title: Assessment of Coronary Artery Disease Before Transcatheter Aortic Valve Replacement: A Randomized, Multicenter, Non-Inferiority Trial
Run by Medical University Innsbruck · NCT07107568 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 700 (estimated) |
| Sponsor | Medical University Innsbruck Academic / other |
| Locations | 2 sites (Innsbruck and 1 other locations) |
| Status | Recruiting |
| Started | August 14, 2025 |
| Main results expected | December 31, 2029 |
| Study ends | December 31, 2029 |
| Registry record updated | October 7, 2026 |
| Trial ID | NCT07107568 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
Medical University of Innsbruck
Innsbruck, Austria Recruiting -
Department of Internal Medicine II, Cardiology and Intensive Care Medicine, Klinikum Wels-Grieskirchen
Wels, 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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
CHATEAU Registry: Real-world outcomes after TAVR
This registry collects real-world data from adults who had TAVR between 2021 and 2025 to see how they do over time and how valve performance holds up.
-
CHORDS Cerebral Protection During TAVR
This study tests whether using the CHORDS Cerebral Protection System during TAVR reduces brain embolic events compared to the Sentinel system in adults with severe aortic stenosis.
-
How the type of sedation affects recovery after TAVR
This study will test whether three common sedation approaches (propofol, dexmedetomidine, or midazolam with fentanyl) change how people recover on the first day after transfemoral TAVR.
-
Using 4D Flow MRI to characterize left ventricular failure
This project will test whether automated 4D Flow MRI analysis can measure left ventricular dysfunction in adults with severe aortic stenosis who are scheduled for TAVR.
-
XTR004 PET heart scan to detect flow‑limiting coronary blockages
This trial tests whether XTR004 PET heart scans can accurately detect significant coronary artery blockages in adults with suspected or known coronary artery disease compared with QCA and FFR.
-
Lesion-specific angina thresholds measured during invasive coronary testing
This project tests whether different coronary narrowings cause angina at different levels of blood-flow reduction in people with stable angina who have two blockages suitable for PCI.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.