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Enrolling by invitation NCT07083986

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

No phase Interventional Ischaemic Stroke Carotid Endarterectomy Carotid Stenting

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Carotid Artery Stent Placement, carotid endarterectomy.
Who it may be relevant to
Registry conditions: Ischaemic Stroke, Carotid Endarterectomy, Carotid Stenting. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Russia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Immediate and Long-term Results of Carotid Endarterectomy and Stenting in the Acute Stage of Ischemic Stroke

Overview

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).

Interventions

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

Primary outcome measures

  • Rate of Hemorrhagic complications (%) [Time frame: "Baseline" "Perioperative/Periprocedural" "up to 30 day" "1 year" "through study completion, an average of 1 year".]
  • 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".]
  • 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".]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

Russia · 1 center
  • Moscow City Clinical Hospital named after V.M. Buyanov — Moscow

Identifiers

NCT: NCT07083986 · 25225062025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗