General Versus Regional Anesthesia for Carotid Endarterectomy at Acute Ischemic Stroke Trial (GRACE AIST)

March 23, 2026 updated by: Pirogov Russian National Research Medical University

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.

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. 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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Regional anesthesia for carotid endarterectomy in patients with acute stage of ischemic stroke.
Procedure: carotid endarterectomy
carotid endarterectomy under local or general anethesia
Active Comparator: General anesthesia for carotid endarterectomy in patients with acute stage of ischemic stroke.
Procedure: carotid endarterectomy
carotid endarterectomy under local or general anethesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rate of perioperative ipsilateral ischemic stroke (%)
Time Frame: in hospital, 30-day, 1 year
in hospital, 30-day, 1 year
Rate of any stroke (%)
Time Frame: in hospital, 30-day, 1 year
in hospital, 30-day, 1 year
Rate of Myocardial infarction (%)
Time Frame: in hospital, 30-day, 1 year
in hospital, 30-day, 1 year
Rate of Hemorrhagic complications (%)
Time Frame: in hospital, 30-day, 1 year
in hospital, 30-day, 1 year
Rate of Surgical site infection (%)
Time Frame: in hospital, 30-day, 1 year
in hospital, 30-day, 1 year
Rate of Death (%)
Time Frame: in hospital, 30-day, 1 year
in hospital, 30-day, 1 year
Rate of main adverse cardiovascular events (%)
Time Frame: in hospital, 30-day, 1 year
in hospital, 30-day, 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pirogov Russian National Research Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

November 1, 2023

First Submitted That Met QC Criteria

December 15, 2023

First Posted (Actual)

December 19, 2023

Study Record Updates

Last Update Posted (Actual)

March 27, 2026

Last Update Submitted That Met QC Criteria

March 23, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1 (Mobile Health and Wellness Program)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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