NCT07083986

Carotid Endarterectomy Versus Stenting in Patients With Acute Stage of Ischemic Stroke.

Immediate and Long-term Results of Carotid Endarterectomy and Stenting in the Acute Stage of Ischemic Stroke

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Pirogov Russian National Research Medical University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this clinical trial is to compare immediate and long-term results of carotid endarterectomy and carotid stenting in acute period of ischemic stroke. Patients who presented with acute stage of ischemic stroke will be treated by carotid artery stenting in 50 cases and by carotid endarterectomy in 50 cases under regional anesthesia. Patient inclusion criteria: 1. Ischemic stroke in the middle cerebral artery territory 2. Ipsilateral stenosis of the internal carotid artery more than 50% 3. Neurological deficit at the time of surgical treatment: the modified Rankin scale (mRs) score of 0-4 and the US National Institutes of Health (NIHSS) stroke scale score no more than 12 4. The size of the ischemia focus: no more than 1/3 in the territory of the middle cerebral artery brain supply 5. Terms of operation: from 1 to 28 days from the moment of ischemic stroke The primary intra-hospital and/or 30-day study endpoints: 1. Perioperative ipsilateral ischemic stroke. 2. Any stroke: contralateral ischemic or any hemorrhagic stroke. 3. Myocardial infarction. 4. Hemorrhagic complications that required surgical revision of the operating wound or transfusion of blood components. 5. Surgical site infection 6. Death 7. Main adverse cardiovascular events (stroke + myocardial infarction + death).

Conditions

• Ischaemic Stroke
• Carotid Endarterectomy
• Carotid Stenting

Interventions

Type	Name	Description
PROCEDURE	Carotid Artery Stent Placement	Carotid Artery Stent Placement was performed according to the standard technique.
PROCEDURE	carotid endarterectomy	Carotid endarterectomy with stenting was performed according to the standard technique. For the purpose of the greatest comparability in the volume of anesthesia, it was decided to use regional anesthesia in all cases, including adequate dynamic observation of neurological status.

Timeline

• Start date: 2025-05-21
• Primary completion: 2026-05-21
• Completion: 2028-05-21
• First posted: 2025-07-24
• Last updated: 2025-07-24

Locations

1 site across 1 country: Russia