Ischaemic StrokeNCT07083986
Carotid Endarterectomy Versus Stenting in Patients With Acute Stage of Ischemic Stroke.
A study testing Carotid Artery Stent Placement and carotid endarterectomy in people with Ischaemic Stroke and Carotid Endarterectomy, run by Pirogov Russian National Research Medical University at 1 site in Russia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischaemic Stroke, Carotid Endarterectomy, Carotid Stenting
- What is being tested?
- Carotid Artery Stent Placement and carotid endarterectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteRussia
- Study dates
- 21 May 2025to 21 May 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 18 years and older
- 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 strok
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Immediate and Long-term Results of Carotid Endarterectomy and Stenting in the Acute Stage of Ischemic Stroke
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:
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
- Ischaemic Stroke, Carotid Endarterectomy, Carotid Stenting
- Being tested
- Carotid Artery Stent Placement, 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 Artery Stent PlacementProcedure or surgery
Carotid Artery Stent Placement was performed according to the standard technique.
carotid endarterectomyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients in acute period of Ischaemic Stroke | Experimental | Not described Receives: Procedure: Carotid Artery Stent Placement; Procedure: carotid endarterectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Hemorrhagic complications (%)
The primary outcome measure was 30-day postoperative intracerebral hemorrhage (ICH)
Measured: "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.
Measured: "Baseline" "Perioperative/Periprocedural" "up to 30 day" "1 year" "through study completion, an average of 1 year".
Rate of any stroke (%)
Measured: "Baseline" "Perioperative/Periprocedural" "up to 30 day" "1 year" "through study completion, an average of 1 year".
Rate of Myocardial infarction (%)
Measured: "Baseline" "Perioperative/Periprocedural" "up to 30 day" "1 year" "through study completion, an average of 1 year".
Rate of Surgical site infection (%)
Measured: "Baseline" "Perioperative/Periprocedural" "up to 30 day" "1 year" "through study completion, an average of 1 year".
Rate of Death (%)
Measured: "Baseline" "Perioperative/Periprocedural" "up to 30 day" "1 year" "through study completion, an average of 1 year".
Rate of main adverse cardiovascular events (%)
Measured: "Baseline" "Perioperative/Periprocedural" "up to 30 day" "1 year" "through study completion, an average of 1 year".
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2025
- Study start21 May 2025
- Primary completion21 May 2027 (estimated)
- Study completion21 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischaemic 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
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pirogov Russian National Research Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pryamikov Aleksandr, Pirogov Russian National Research Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07083986
- Sponsor's protocol ID
- 25225062025
- Status last verified
- Jul 2026
- First submitted
- 5 Jul 2025
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate and Long-term Results of Carotid Endarterectomy and Stenting in the Acute Stage of Ischemic Stroke
- ClinicalTrials.gov ID
- NCT07083986
- Acronym / sponsor ID
- 25225062025
- Conditions
- Ischaemic Stroke, Carotid Endarterectomy, Carotid Stenting
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Pirogov Russian National Research Medical UniversityUniversity, hospital or other
- Study start
- 21 May 2025 (actual)
- Primary completion
- 21 May 2027 (estimated)
- Study completion
- 21 May 2028 (estimated)
- First posted
- 24 Jul 2025 (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 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:
- 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
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients in acute period of Ischaemic Stroke | Experimental | Procedure: Carotid Artery Stent Placement, Procedure: carotid endarterectomy |
Who may qualify
- Ages
- 18 years and older
- 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 strok
Key exclusion criteria (0 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 Artery Stent PlacementCarotid Artery Stent Placement was performed according to the standard technique. | Procedure or surgery | Patients in acute period of Ischaemic Stroke |
| carotid endarterectomyCarotid 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. | Procedure or surgery | Patients in acute period of Ischaemic Stroke |
Primary outcome
Rate of Hemorrhagic complications (%)
Time frame: "Baseline" "Perioperative/Periprocedural" "up to 30 day" "1 year" "through study completion, an average of 1 year".
The primary outcome measure was 30-day postoperative intracerebral hemorrhage (ICH)
Rate of perioperative ipsilateral ischemic stroke (%)
Time frame: "Baseline" "Perioperative/Periprocedural" "up to 30 day" "1 year" "through study completion, an average of 1 year".
The primary endpoint was ipsilateral stroke < 30 days.
Rate of any stroke (%)
Time frame: "Baseline" "Perioperative/Periprocedural" "up to 30 day" "1 year" "through study completion, an average of 1 year".
Rate of Myocardial infarction (%)
Time frame: "Baseline" "Perioperative/Periprocedural" "up to 30 day" "1 year" "through study completion, an average of 1 year".
Rate of Surgical site infection (%)
Time frame: "Baseline" "Perioperative/Periprocedural" "up to 30 day" "1 year" "through study completion, an average of 1 year".
Rate of Death (%)
Time frame: "Baseline" "Perioperative/Periprocedural" "up to 30 day" "1 year" "through study completion, an average of 1 year".
Rate of main adverse cardiovascular events (%)
Time frame: "Baseline" "Perioperative/Periprocedural" "up to 30 day" "1 year" "through study completion, an average of 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 29 Jul 2026.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Artery Stent Placement and carotid endarterectomy in people with Ischaemic Stroke and Carotid Endarterectomy, 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 0 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: enrolling by invitation, as of the sponsor's last update on 29 Jul 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Hemorrhagic complications (%) (time frame: "Baseline" "Perioperative/Periprocedural" "up to 30 day" "1 year" "through study completion, an average of 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 29 Jul 2026.