Ignite Creation Date:
2024-05-06 @ 7:58 PM
Last Modification Date:
2024-10-26 @ 3:18 PM
Study NCT ID:
NCT06205810
Status:
RECRUITING
Last Update Posted:
2024-01-16
First Post:
2023-11-28
Brief Title:
The COMPLETE Study
Sponsor:
CoreAalst BV
Organization:
CoreAalst BV
Study Overview
Official Title:
Comprehensive Anatomical and Physiological Evaluation of Patients With Stable Coronary Artery Disease
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COMPLETE
Brief Summary:
The COMPLETE study is a single-centre investigator-initiated study of patients with an indication for invasive coronary angiography with CCTA performed during the diagnostic evaluation After identifying the presence of a coronary stenosis defined as an epicardial lesion 50 stenosis on CCTA patients eligible for the study will be invited to participate
The main aim of this trial is to assess the accuracy of coronary CT angiography to quantify total atheroma volume with intravascular ultrasound as reference
Patients will be divided into 2 sub-groups
Cohort 1 Patients with stable coronary artery disease or stabilized acute coronary syndromes with a clinical indication for invasive coronary angiography
Cohort 2 Patients previously revascularized with a metallic stent with a clinical indication for invasive coronary angiography
In both cohorts patients should have undergone coronary CT angiography as part of the standard of care
Patients included in the study will be managed according to the standard of care for the assessment of coronary artery disease Clinical follow-up will be collected until 3 years follow-up
The main aim of this trial is to assess the accuracy of coronary CT angiography to quantify total atheroma volume with intravascular ultrasound as reference
Patients will be divided into 2 sub-groups
Cohort 1 Patients with stable coronary artery disease or stabilized acute coronary syndromes with a clinical indication for invasive coronary angiography
Cohort 2 Patients previously revascularized with a metallic stent with a clinical indication for invasive coronary angiography
In both cohorts patients should have undergone coronary CT angiography as part of the standard of care
Patients included in the study will be managed according to the standard of care for the assessment of coronary artery disease Clinical follow-up will be collected until 3 years follow-up
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None
Is an FDA AA801 Violation?:
None