Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06546761
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-06
Brief Title:
Selective Coronary Revascularization in Carotid Artery Disease Patients After Carotid Revascularization SCORECAD Trial
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Selective Coronary Revascularization in Carotid Artery Disease Patients After Carotid Revascularization SCORECAD Trial
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objective of this study is to determine whether among symptomatic and asymptomatic carotid artery stenosis CAS patients with no known coronary artery disease CAD who had undergone carotid artery revascularization endarterectomy of stenting a strategy of best medical therapy BMT plus selective coronary revascularization based on FFRct assessment of lesion-specific coronary ischemia can reduce adverse cardiac events and improve survival compared to BMT alone Lesion-specific coronary ischemia is defined as FFRCT 080 distal to stenosis in a major 2 mm coronary artery with severe ischemia defined as FFRCT 075
Detailed Description:
This study targets a population of patients with symptomatic or asymptomatic carotid artery stenosis CAS symptomatic to asymptomatic in 11 ratio and no prior cardiac history no myocardial infarction no coronary angiography or coronary computed tomography angiography CTA and no coronary revascularization PCI or CABG who have undergone successful carotid artery revascularization with planned post-operative best medical therapy Within 14 days following carotid revascularization patients will be randomly assigned to BMT alone or BMT plus coronary CT angiography which must be completed within 14 days of randomization and FFRct analysis to determine the functional significance of coronary lesions identified on the CT scan Results of the CT scan and FFRCT analysis in patients randomized to the CT-FFRct group will be provided to treating physicians to help guide patient management with Vascular Heart Team consideration for coronary angiography and revascularization as appropriate for each patient Coronary revascularization PCI or CABG if indicated is strongly recommended within 3 months from the randomization Clinical follow up based on date of randomization is planned 6 months one and 2 years Additional long-term follow up out to 5-years is planned for participating centers An independent academic clinical events committee will adjudicate all endpoints in a blinded manner The definition of outcome events will be in accordance with Academic Research Consortium-2 consensus document
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None