ClinicalTrials.gg
Enrolling by invitationNCT07083986Updated Jul 29, 2026

Carotid Endarterectomy Versus Stenting in Patients With Acute Stage of Ischemic Stroke.

An interventional study of Carotid Artery Stent Placement and carotid endarterectomy in Ischaemic Stroke, Carotid Endarterectomy and Carotid Stenting, sponsored by Pirogov Russian National Research Medical University. Enrolling by invitation at 1 site in Russia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-29.

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

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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 cases under regional 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

  • Ischaemic Stroke
  • Carotid Endarterectomy
  • Carotid Stenting

Browse trials for

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 50 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
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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 strok

Exclusion criteria

Exclusion Criteria:

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    Patients in acute period of Ischaemic Stroke

    Procedure: Carotid Artery Stent Placement · Procedure: carotid endarterectomy

Interventions

  • ProcedureCarotid Artery Stent Placement

    Carotid Artery Stent Placement was performed according to the standard technique.

  • Procedurecarotid endarterectomy

    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.

06

What researchers measure

Primary outcomes

  1. Rate of Hemorrhagic complications (%)

    The primary outcome measure was 30-day postoperative intracerebral hemorrhage (ICH)

    Time frame: "Baseline" "Perioperative/Periprocedural" "up to 30 day" "1 year" "through study completion, an average of 1 year".

  2. Rate of perioperative ipsilateral ischemic stroke (%)

    The primary endpoint was ipsilateral stroke \< 30 days.

    Time frame: "Baseline" "Perioperative/Periprocedural" "up to 30 day" "1 year" "through study completion, an average of 1 year".

  3. Rate of any stroke (%)

    Time frame: "Baseline" "Perioperative/Periprocedural" "up to 30 day" "1 year" "through study completion, an average of 1 year".

  4. Rate of Myocardial infarction (%)

    Time frame: "Baseline" "Perioperative/Periprocedural" "up to 30 day" "1 year" "through study completion, an average of 1 year".

  5. Rate of Surgical site infection (%)

    Time frame: "Baseline" "Perioperative/Periprocedural" "up to 30 day" "1 year" "through study completion, an average of 1 year".

  6. Rate of Death (%)

    Time frame: "Baseline" "Perioperative/Periprocedural" "up to 30 day" "1 year" "through study completion, an average of 1 year".

  7. 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".

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 29, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07083986
Lead sponsor
Pirogov Russian National Research Medical University
Responsible party
Pryamikov Aleksandr (MD, PhD (DMedSc [Russia]), Associate Professor, Pirogov Russian National Research Medical University) — Principal investigator
First posted
Jul 24, 2025
Start date
May 21, 2025
Primary completion
May 21, 2027 (estimated)
Completion
May 21, 2028 (estimated)
Last update
Jul 29, 2026

Oversight

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

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

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

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion