" Endarterectomy Combined With Optimal Medical Therapy (OMT) vs OMT Alone in Patients With Asymptomatic Severe Atherosclerotic Carotid Artery Stenosis at Higher-than-average Risk of Ipsilateral Stroke "

• Status: Not yet recruiting
• Trial end date: 2025-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether carotid surgery combined with optimal medical therapy improves long-term survival free of ipsilateral stroke in patients with asymptomatic carotid stenosis at higher-than-average risk of ipsilateral stroke when compared with optimal medical therapy alone.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre Hospitalier St Anne
• Collaborator: Hôpitaux Universitaires Paris Ile-de-Franc Ouest

Criteria

Inclusion Criteria:

• Age 50 years or over

• No ipsilateral stroke or TIA within 180 days of randomization

• Atherosclerotic carotid stenosis between 70 and 99% (NASCET method)

• At least one of the following markers of ipsilateral stroke risk:

• Silent brain infarction on MRI, DWi, consistent with embolism from or hemodynamic consequences of the qualifyiing stenosis

• History of contralateral TIA or ischemic stroke due to atherosclerotic carotid disease

• Predominantly echolucent plaque on ultrasound

• Rapid (within 1 year) carotid stenosis progresion

• TCD-detected microembolic signals

• Impairment of TCD-measured cerebral vasomotor reserve

• Intraplaque haemorrhage on magnetic resonance imaging

• Rapid and severe stenosis progression

• Patient is able and willing to give informed consent

Exclusion Criteria:

• Previous revascularization procedure in the artery to be randomised

• Patients not suitable for endarterectomy due to anatomical factors

• Carotid stenosis caused by non-atherosclerotic disease e.g. neck radiotherapy or fibromuscular disease

• Patients who have had contralateral carotid artery or vertebral artery or intracranial artery revascularisation within 6 weeks prior to randomisation

• Patients with planned revascularisation of the contralateral carotid artery or a vertebral artery or an intracranial artery within 6 weeks after randomisation or the date of CEA

• Patients who have had coronary artery bypass grafting within 3 months prior to randomisation or other major surgery within 6 weeks prior to randomisation

• Patients with planned coronary artery bypass grafting or other major surgery within 6 weeks after CEA of the artery considered for treatment in the trial

• Patients with pre-existing disability (modified Rankin score greater than 2)

• Patients who have a low 5-year life expectancy (see appendix for definition)

• Patients intolerant or allergic to all of the medications available for OMT

• Patients in clinical trials of investigational medicinal products or who have been in clinical trials within the last 4 months will not be enrolled unless otherwise agreed

• Patients who are known to be pregnant

• Patients unwilling or unable to participate in follow-up