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NCT07016477 · ClinicalTrials.gov registry record
Prospective Registry of Patients Undergoing Cardiac CT With NAEOTOM Alpha PCD-CT Before TAVI Procedure
A clinical trial of Coronary Artery Disease and Aortic Valve Stenosis, sponsored by Semmelweis University.
- Recruiting
- Registry status
- 1,000
- Enrollment target
- 7
- Study locations
NCT07016477 is a study of Coronary Artery Disease and Aortic Valve Stenosis that is actively recruiting participants, run by Semmelweis University. The registered enrollment target is 1,000 participants, below the 1,282-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (22% lower). The trial reports 7 study locations across 2 states.
The verdict
NCT07016477, a study of Coronary Artery Disease and Aortic Valve Stenosis, is actively recruiting participants, sponsored by Semmelweis University.
- RECRUITING
- Registry status
- 1,000 participants
- Enrollment target
- 7
- Study locations
Study 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 Studied
Interventions
- DIAGNOSTIC_TEST Ultra-High Resolution Photon Counting Detector Coronary Computed Tomography Angiography
Study Locations (7)
Other
- Albert-Ludwigs-Universität Freiburg - Freiburg im Breisgau
- University Medical Center Mainz - Mainz
- Universitätsklinikum Tübingen - Tübingen
- Semmelweis University - Budapest
- Maastricht University - Maastricht
- University Hospital of Zürich - Zurich
South Carolina
- Medical University of South Carolina - Charleston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,000 participants |
| Start Date | 2024-06-01 |
| Est. Completion | 2030-05-30 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07016477
The ClinicalTrials.gov registry entry for NCT07016477 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 1,000 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,282-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (22% lower). The listed sponsor is Semmelweis University, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Coronary Artery Disease appearing as the primary indexed condition, and to 1 intervention - of which Ultra-High Resolution Photon Counting Detector Coronary Computed Tomography Angiography is the first listed.
NCT07016477 reports 7 study locations spanning 2 distinct geographic areas - top geographies include Other, South Carolina.
Frequently Asked Questions
What is clinical trial NCT07016477 about?
NCT07016477 is a clinical study titled "Prospective Registry of Patients Undergoing Cardiac CT With NAEOTOM Alpha PCD-CT Before TAVI Procedure". 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 c...
What is the current status of trial NCT07016477?
This trial is currently recruiting. The enrollment target is 1,000 participants. The study started on 2024-06-01. Estimated completion is 2030-05-30.
What conditions does trial NCT07016477 study?
This clinical trial studies the following conditions: Coronary Artery Disease, Aortic Valve Stenosis, Tomography, X-Ray Computed.
What interventions are being tested in trial NCT07016477?
The interventions under investigation include: Ultra-High Resolution Photon Counting Detector Coronary Computed Tomography Angiography (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT07016477?
This trial is sponsored by Semmelweis University, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07016477 being conducted?
This trial has 7 study locations across South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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