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

NCT ID: NCT07083986

Last Updated: 2025-07-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-21

Study Completion Date

2028-05-21

Brief Summary

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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).

Detailed Description

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Conditions

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Ischaemic Stroke Carotid Endarterectomy Carotid Stenting

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Patients in acute period of Ischaemic Stroke

Group Type EXPERIMENTAL

Carotid Artery Stent Placement

Intervention Type PROCEDURE

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

carotid endarterectomy

Intervention Type PROCEDURE

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.

Interventions

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Carotid Artery Stent Placement

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

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pirogov Russian National Research Medical University

OTHER

Sponsor Role lead

Responsible Party

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Pryamikov Aleksandr

MD, PhD (DMedSc [Russia]), Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Moscow City Clinical Hospital named after V.M. Buyanov

Moscow, , Russia

Site Status

Countries

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Russia

Other Identifiers

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25225062025

Identifier Type: -

Identifier Source: org_study_id

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