Recruiting

PCD-CT vs. ICA

Sponsor:

Semmelweis University

Code:

NCT07016477

Conditions

Coronary Artery Disease

Aortic Valve Stenosis

Tomography, X-Ray Computed

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Ultra-High Resolution Photon Counting Detector Coronary Computed Tomography Angiography

Study Details

Brief summary:

The clinical and demographic characteristics of patients undergoing transcatheter aortic valve implantation (TAVI) pose unique challenges for coronary computed tomography (CT) imaging, as this patient population is mainly composed of elderly, frail individuals with severe aortic stenosis, multiple comorbidities, high prevalence of heavily calcified coronary artery disease (CAD) and revascularized coronary arteries. Such vulnerable patients could benefit from a more precise assessment and characterization of their CAD with ultra-high resolution (UHR) photon-counting detector (PCD) CT that would potentially avoid the need for pre-implantation invasive coronary angiography (ICA). This international multicenter prospective registry study aims to investigate the feasibility and diagnostic accuracy of PCD-CT in the assessment of CAD in the high-risk population of patients undergoing TAVI, as compared to ICA.

Conditions

Coronary Artery Disease

Aortic Valve Stenosis

Tomography, X-Ray Computed

Study ID

NCT07016477

Start date

Jun 1, 2024

Status verified date

Jun, 2025

Completion date

May 30, 2030

Anticipated

Primary completion date

May 30, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Clinically indicated TAVI
  • Clinically indicated CT and invasive coronary angiography
  • There are no contraindications to CT angiography.
  • Understanding and signing the consent form

Exclusion Criteria:

  • Pregnancy or breastfeeding
  • Chronic renal failure (eGFR <30 ml/m2)
  • Active oncological treatment
  • Any condition for which TAVI is contraindicated and therefore no prior radiological investigation of TAVI is indicated

Study Design

Enrollment

1000 participants

Anticipated

Interventions and Outcome Measures

Arms

Aortic stenosis

Patients with aortic valve disease for whom transcatheter aortic valve implantation is indicated and who present for pre-interventional evaluation will be enrolled after written consent.

Interventions

Ultra-High Resolution Photon Counting Detector Coronary Computed Tomography Angiography

Clinically indicated Ultra-High Resolution Photon-Counting Detector Coronary Computed Tomography Angiography (UHR PCD-CT CCTA) for the pre-procedural evaluation of patients scheduled to undergo transcatheter aortic valve implantation.

Primary outcome measure

  • Diagnostic Accuracy of Ultra-High Resolution Photon-Counting Detector Coronary Computed Tomography Angiography (UHR PCD-CT CCTA) [ Time Frame: through study completion, an average of 2 years ]

Central Contacts and Locations

Central contacts

Pál Maurovich-Horvat, MD, PhD, DSc

+3614591500maurovich-horvat.pal@semmelweis.hu

Locations

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

Akos Varga-Szemes, MD, PhD

+1843-876-7146vargaasz@musc.edu

Principal Investigator:

U. Joseph Schoepf, MD

More Information

Sponsor

Semmelweis University

Last update posted

Jun 11, 2025

Last verified

Jun, 2025

Keywords

  • photon-counting detector computed tomography

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Semmelweis University on 2025-06-11.