Acute Ischemic StrokeGRACE AISTNCT06175715
General Versus Regional Anesthesia for Carotid Endarterectomy at Acute Ischemic Stroke Trial
A study testing carotid endarterectomy in people with Acute Ischemic Stroke, run by Pirogov Russian National Research Medical University at 1 site in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- carotid endarterectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteRussia
- Study dates
- 1 Jul 2024to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Russia1 site, 1 recruiting
- Recruiting
Pryamikov Aleksandr
Moscow
Aleksandr Pryamikov, 89032862552, pryamikov80@rambler.ru
About this study
Official title: 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:
Read more
- Ischemic stroke in the middle cerebral artery territory
- Ipsilateral stenosis of the internal carotid artery more than 50%
- 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
- The size of the ischemia focus: no more than 1/3 in the territory of the middle cerebral artery brain supply
- Terms of operation: from 1 to 28 days from the moment of ischemic stroke
The primary intra-hospital and/or 30-day study endpoints:
- Perioperative ipsilateral ischemic stroke.
- Any stroke: contralateral ischemic or any hemorrhagic stroke.
- Myocardial infarction.
- Hemorrhagic complications that required surgical revision of the operating wound or transfusion of blood components.
- Surgical site infection
- Death
- Main adverse cardiovascular events (stroke + myocardial infarction + death).
- Conditions
- Acute Ischemic Stroke
- Being tested
- carotid endarterectomy
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
carotid endarterectomyProcedure or surgery
carotid endarterectomy under local or general anethesia
| Study group | Role | What they receive |
|---|---|---|
| Regional anesthesia for carotid endarterectomy in patients with acute stage of ischemic stroke. | Active comparator | Not described Receives: Procedure: carotid endarterectomy |
| General anesthesia for carotid endarterectomy in patients with acute stage of ischemic stroke. | Active comparator | Not described Receives: Procedure: carotid endarterectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of perioperative ipsilateral ischemic stroke (%)
Measured: in hospital, 30-day, 1 year
Rate of any stroke (%)
Measured: in hospital, 30-day, 1 year
Rate of Myocardial infarction (%)
Measured: in hospital, 30-day, 1 year
Rate of Hemorrhagic complications (%)
Measured: in hospital, 30-day, 1 year
Rate of Surgical site infection (%)
Measured: in hospital, 30-day, 1 year
Rate of Death (%)
Measured: in hospital, 30-day, 1 year
Rate of main adverse cardiovascular events (%)
Measured: in hospital, 30-day, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2023
- Study start1 Jul 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pirogov Russian National Research Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06175715
- Sponsor's protocol ID
- 1
- Acronym
- GRACE AIST
- Status last verified
- Mar 2026
- First submitted
- 1 Nov 2023
- Last updated
- 27 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT06175715
- Acronym / sponsor ID
- GRACE AIST / 1
- Conditions
- Acute Ischemic Stroke
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Pirogov Russian National Research Medical UniversityUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 19 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Ischemic stroke in the middle cerebral artery territory
- Ipsilateral stenosis of the internal carotid artery more than 50%
- 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
- The size of the ischemia focus: no more than 1/3 in the territory of the middle cerebral artery brain supply
- Terms of operation: from 1 to 28 days from the moment of ischemic stroke
The primary intra-hospital and/or 30-day study endpoints:
- Perioperative ipsilateral ischemic stroke.
- Any stroke: contralateral ischemic or any hemorrhagic stroke.
- Myocardial infarction.
- Hemorrhagic complications that required surgical revision of the operating wound or transfusion of blood components.
- Surgical site infection
- Death
- Main adverse cardiovascular events (stroke + myocardial infarction + death).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| carotid endarterectomycarotid endarterectomy under local or general anethesia | Procedure or surgery | 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. |
Primary outcome
Rate of perioperative ipsilateral ischemic stroke (%)
Time frame: in hospital, 30-day, 1 year
Rate of any stroke (%)
Time frame: in hospital, 30-day, 1 year
Rate of Myocardial infarction (%)
Time frame: in hospital, 30-day, 1 year
Rate of Hemorrhagic complications (%)
Time frame: in hospital, 30-day, 1 year
Rate of Surgical site infection (%)
Time frame: in hospital, 30-day, 1 year
Rate of Death (%)
Time frame: in hospital, 30-day, 1 year
Rate of main adverse cardiovascular events (%)
Time frame: in hospital, 30-day, 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing carotid endarterectomy in people with Acute Ischemic Stroke, run by Pirogov Russian National Research Medical University at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of perioperative ipsilateral ischemic stroke (%) (time frame: in hospital, 30-day, 1 year). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.