NCT06175715

Brief Summary

The study is planned to evaluate the effectiveness and safety of two types of anesthesia (regional and general) for carotid endarterectomy in 100 patients with acute stage of stroke: 50 patients will be operated under regional anesthesia and the remaining 50 patients under general 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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
32mo left

Started Jul 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress42%
Jul 2024Dec 2028

First Submitted

Initial submission to the registry

November 1, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 19, 2023

Completed
7 months until next milestone

Study Start

First participant enrolled

July 1, 2024

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

March 27, 2026

Status Verified

March 1, 2026

Enrollment Period

2.5 years

First QC Date

November 1, 2023

Last Update Submit

March 23, 2026

Conditions

Acute Ischemic Stroke

Outcome Measures

Primary Outcomes (7)

  • Rate of perioperative ipsilateral ischemic stroke (%)

    in hospital, 30-day, 1 year

  • Rate of any stroke (%)

    in hospital, 30-day, 1 year

  • Rate of Myocardial infarction (%)

    in hospital, 30-day, 1 year

  • Rate of Hemorrhagic complications (%)

    in hospital, 30-day, 1 year

  • Rate of Surgical site infection (%)

    in hospital, 30-day, 1 year

  • Rate of Death (%)

    in hospital, 30-day, 1 year

  • Rate of main adverse cardiovascular events (%)

    in hospital, 30-day, 1 year

Study Arms (2)

Regional anesthesia for carotid endarterectomy in patients with acute stage of ischemic stroke.

ACTIVE COMPARATOR
Procedure: carotid endarterectomy

General anesthesia for carotid endarterectomy in patients with acute stage of ischemic stroke.

ACTIVE COMPARATOR
Procedure: carotid endarterectomy

Interventions

carotid endarterectomyPROCEDURE

carotid endarterectomy under local or general anethesia

General anesthesia for carotid endarterectomy in patients with acute stage of ischemic stroke.Regional anesthesia for carotid endarterectomy in patients with acute stage of ischemic stroke.

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (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 stroke

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pryamikov Aleksandr

Moscow, Russia

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Endarterectomy, Carotid

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

EndarterectomyVascular Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 2023

First Posted

December 19, 2023

Study Start

July 1, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2028

Last Updated

March 27, 2026

Record last verified: 2026-03

Locations

RU(1)