Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 12:38 PM
Ignite Modification Date:
2025-12-24 @ 12:38 PM
NCT ID:
NCT06546761
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 ≤0.80 distal to stenosis in a major (≥2 mm) coronary artery with severe ischemia defined as FFRCT ≤0.75.
Detailed Description:
This study targets a population of patients with symptomatic or asymptomatic carotid artery stenosis (CAS) (symptomatic to asymptomatic in 1:1 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:
NCT06546761
Study Brief:
Protocol Section:
NCT06546761