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

NCT07083986 | Enrolling By Invitation

• 1 other identifier: 25225062025
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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. 1.Ischemic stroke in the middle cerebral artery territory
2. 2.Ipsilateral stenosis of the internal carotid artery more than 50%
3. 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. 4.The size of the ischemia focus: no more than 1/3 in the territory of the middle cerebral artery brain supply
5. 5.Terms of operation: from 1 to 28 days from the moment of ischemic stroke
6. 6.Perioperative ipsilateral ischemic stroke.
7. 7.Any stroke: contralateral ischemic or any hemorrhagic stroke.
8. 8.Myocardial infarction.
9. 9.Hemorrhagic complications that required surgical revision of the operating wound or transfusion of blood components.
10. 10.Surgical site infection
11. 11.Death
12. 12.Main adverse cardiovascular events (stroke + myocardial infarction + death).

Conditions

Ischaemic Stroke; Carotid Endarterectomy; Carotid Stenting

Outcome Measures

Primary Outcomes (7)

• Rate of Hemorrhagic complications (%)

  The primary outcome measure was 30-day postoperative intracerebral hemorrhage (ICH)

  "Baseline" "Perioperative/Periprocedural" "up to 30 day" "1 year" "through study completion, an average of 1 year".

• Rate of perioperative ipsilateral ischemic stroke (%)

  The primary endpoint was ipsilateral stroke \< 30 days.

  "Baseline" "Perioperative/Periprocedural" "up to 30 day" "1 year" "through study completion, an average of 1 year".

• Rate of any stroke (%)

  "Baseline" "Perioperative/Periprocedural" "up to 30 day" "1 year" "through study completion, an average of 1 year".

• Rate of Myocardial infarction (%)

  "Baseline" "Perioperative/Periprocedural" "up to 30 day" "1 year" "through study completion, an average of 1 year".

• Rate of Surgical site infection (%)

  "Baseline" "Perioperative/Periprocedural" "up to 30 day" "1 year" "through study completion, an average of 1 year".

• Rate of Death (%)

  "Baseline" "Perioperative/Periprocedural" "up to 30 day" "1 year" "through study completion, an average of 1 year".

• Rate of main adverse cardiovascular events (%)

  "Baseline" "Perioperative/Periprocedural" "up to 30 day" "1 year" "through study completion, an average of 1 year".

Study Arms (1)

Patients in acute period of Ischaemic Stroke

EXPERIMENTAL

Procedure: Carotid Artery Stent Placement; Procedure: carotid endarterectomy

Interventions

Carotid Artery Stent Placement PROCEDURE

Carotid Artery Stent Placement was performed according to the standard technique.

Patients in acute period of Ischaemic Stroke

carotid endarterectomy PROCEDURE

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.

Patients in acute period of Ischaemic Stroke

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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 strok

Sponsors & Collaborators

• Pirogov Russian National Research Medical University: lead

Study Sites (1)

Moscow City Clinical Hospital named after V.M. Buyanov

Moscow, Russia

Location

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Endarterectomy, Carotid

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Endarterectomy; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD (DMedSc [Russia]), Associate Professor

Study Record Dates

• First Submitted: July 5, 2025
• First Posted: July 24, 2025
• Study Start: May 21, 2025
• Primary Completion (Estimated): May 21, 2026
• Study Completion (Estimated): May 21, 2028
• Last Updated: July 24, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share

Locations

RU (1)