Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2025-12-25 @ 9:54 PM
Study NCT ID:
NCT05551351
Status:
TERMINATED
Last Update Posted:
2025-04-16
First Post:
2022-09-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
CT in Calcified Coronary Arteries With Photon Counting Detector
Sponsor:
Region Örebro County
Organization:
Study Overview
Official Title:
CT av förkalkade kranskärl Med fotonräknarteknik
Status:
TERMINATED
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Enrollment rate too slow to reach anticipated number of participants.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CCT-PCD-1
Brief Summary:
Coronary CT angiography is challenging in patients with more than mildly calcified coronary vessels, because of calcium artefacts that prevents evaluation of the lumen. The purpose of the CCT-PCD-1-study is to evaluate the diagnostic accuracy and image quality in coronary CT angiography using a commercially available CT system equipped with a photon counting detector technology.
Patients referred for cardiac CT and conventional coronary angiography as part of routine preoperative evaluation before Transcatheter Aortic Valve Implantation (TAVI) will be asked for inclusion in the study. This group of patients has generally a coronary artery calcium burden and perform cardiac CT and coronary angiography as part of routine care.
The diagnostic accuracy concerning significant coronary artery stenosis on the preoperative CT will be evaluated with the conventional coronary angiography as reference. Also, CT examination image quality will be evaluated.
Patients referred for cardiac CT and conventional coronary angiography as part of routine preoperative evaluation before Transcatheter Aortic Valve Implantation (TAVI) will be asked for inclusion in the study. This group of patients has generally a coronary artery calcium burden and perform cardiac CT and coronary angiography as part of routine care.
The diagnostic accuracy concerning significant coronary artery stenosis on the preoperative CT will be evaluated with the conventional coronary angiography as reference. Also, CT examination image quality will be evaluated.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: