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RecruitingNCT06175715GRACE AISTUpdated Mar 27, 2026

General Versus Regional Anesthesia for Carotid Endarterectomy at Acute Ischemic Stroke Trial

An interventional study of carotid endarterectomy in Acute Ischemic Stroke, sponsored by Pirogov Russian National Research Medical University. Recruiting at 1 site in Russia. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-03-27.

Sponsored by Pirogov Russian National Research Medical University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Jul 2024; still recruiting 2 years 4 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
40 Years to 80 Years
Sex
All
01

Study 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. 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).
02

Conditions studied

  • Acute Ischemic Stroke

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03

In context

Ischemic Stroke

2,612 studies on the registry are indexed under Ischemic Stroke; 971 are open to participants now.

This study's planned enrollment of 100 is below the median of 120 across 1,776 interventional studies indexed under Ischemic Stroke.

Browse Ischemic Stroke studies →

Lead sponsor

Pirogov Russian National Research Medical University is the lead sponsor of 57 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

-

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Single (Participant)
Enrollment
100 participants (estimated)

Study arms

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

    Procedure: carotid endarterectomy

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

    Procedure: carotid endarterectomy

Interventions

  • Procedurecarotid endarterectomy

    carotid endarterectomy under local or general anethesia

06

What researchers measure

Primary outcomes

  1. Rate of perioperative ipsilateral ischemic stroke (%)

    Time frame: in hospital, 30-day, 1 year

  2. Rate of any stroke (%)

    Time frame: in hospital, 30-day, 1 year

  3. Rate of Myocardial infarction (%)

    Time frame: in hospital, 30-day, 1 year

  4. Rate of Hemorrhagic complications (%)

    Time frame: in hospital, 30-day, 1 year

  5. Rate of Surgical site infection (%)

    Time frame: in hospital, 30-day, 1 year

  6. Rate of Death (%)

    Time frame: in hospital, 30-day, 1 year

  7. Rate of main adverse cardiovascular events (%)

    Time frame: in hospital, 30-day, 1 year

07

Study locations

1 of 1 sites recruiting
  • Pryamikov Aleksandr
    Moscow, Russia
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jul 2024 (actual). Primary completion is estimated for Dec 2026, 29 months after the start.

Of 572 non-industry interventional studies with no phase under Ischemic Stroke, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 48. This study's planned 29 months is close to that.

Counting every sponsor, half of 653 studies reached it within 27 months; a quarter within 14 and three quarters within 48.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 1, 2023
First posted
Dec 19, 2023
StartActual
Jul 1, 2024
Primary completionEst.
Dec 31, 2026
CompletionEst.
Dec 31, 2028
Last update
Mar 27, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06175715
Lead sponsor
Pirogov Russian National Research Medical University
Responsible party
Sponsor
First posted
Dec 19, 2023
Start date
Jul 1, 2024
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2028 (estimated)
Last update
Mar 27, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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Discussion

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