Reconstruction of the Carotid Bifurcation in Patients With Arterial Hypertension of 2-3 Degrees

NCT ID: NCT05931003

Last Updated: 2024-12-16

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

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-01

Study Completion Date

2026-09-01

Brief Summary

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Carotid endarterectomy (CEA) is a well-established procedure for preventing ischemic brain damage. Stenosis of the precerebral vessels are often combined with arterial hypertension. In recent decades, many works have appeared that indicate that the course of arterial hypertension (AH) changes after CEA. However, it remains unknown how this is related to the choice of surgical tactics.

Detailed Description

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Purpose of the study: to substantiate the choice of the method of surgical treatment in patients with a combination of hemodynamically significant stenosis of the carotid bifurcation and arterial hypertension of 2-3 degrees.

Tasks:

1. To study the course of hypertension after carotid endarterectomy with removal of the carotid glomus.
2. To study the course of hypertension in patients after stenting of the internal carotid artery.
3. To substantiate the strategy for performing carotid endarterectomy in patients with bilateral significant lesions of the internal carotid artery.
4. To substantiate the choice of a surgical treatment strategy in patients with significant stenosis of the carotid bifurcation and 2-3 degree of hypertension.

Methods for examining patients: collection of complaints and anamnesis, objective examination, questioning of patients, instrumental examination (ultrasound of BCS, daily monitoring of blood pressure, CT of the brain, cerebral angiography).

As a result of the study, the optimal tactics of surgical treatment in patients with carotid artery stenosis and the presence of hypertension will be determined.

Conditions

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Hypertension Carotid Stenosis Symptomatic Carotid Artery Stenosis

Keywords

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Hypertension Carotid Stenosis Symptomatic Carotid Artery Stenosis Glomus ectomy Carotid endarterectomy Carotid Stenting

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Carotid artery stenting

Carotid artery stenting

Group Type EXPERIMENTAL

Carotid stenting

Intervention Type PROCEDURE

In carotid stenting, a long, hollow tube (catheter) is threaded through the arteries to the narrowed carotid artery in the neck. A metal mesh tube (stent) is inserted into the vessel to serve as a scaffold that helps prevent the artery from narrowing again. The catheter and the filter - which catches any debris that may break off during the procedure - are removed.

Carotid endarterectomy

Carotid endarterectomy

Group Type ACTIVE_COMPARATOR

Carotid endarterectomy

Intervention Type PROCEDURE

Carotid endarterectomy is a procedure to treat carotid artery disease. In carotid endarterectomy receive general anesthesia. Surgeon makes an incision along the front of your neck, opens your carotid artery and removes the plaques that are clogging artery. Then, surgeon repairs the artery with stitches or a patch made with a vein or artificial material (patch graft).

Sometimes surgeons may use another technique called eversion carotid endarterectomy. This involves cutting the carotid artery and turning it inside out, then removing the plaque. Surgeon then reattaches the artery.

Interventions

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Carotid stenting

In carotid stenting, a long, hollow tube (catheter) is threaded through the arteries to the narrowed carotid artery in the neck. A metal mesh tube (stent) is inserted into the vessel to serve as a scaffold that helps prevent the artery from narrowing again. The catheter and the filter - which catches any debris that may break off during the procedure - are removed.

Intervention Type PROCEDURE

Carotid endarterectomy

Carotid endarterectomy is a procedure to treat carotid artery disease. In carotid endarterectomy receive general anesthesia. Surgeon makes an incision along the front of your neck, opens your carotid artery and removes the plaques that are clogging artery. Then, surgeon repairs the artery with stitches or a patch made with a vein or artificial material (patch graft).

Sometimes surgeons may use another technique called eversion carotid endarterectomy. This involves cutting the carotid artery and turning it inside out, then removing the plaque. Surgeon then reattaches the artery.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Presence of symptomatic ICA stenosis 70-90%
* Arterial hypertension of 2 or 3 degrees
* CEA operation with carotid glomus removal or ICA stenting operation

Exclusion Criteria

* severe diabetes
* traumatic brain injury in history
* IHD, stable angina pectoris 3-4 FC.
* presence of clinical signs of vertebrobasilar insufficiency
* the presence of significant stenosis of the renal arteries
* CKD stages 3b-5
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Samara State Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Samara State Medical University

Samara, , Russia

Site Status

Countries

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Russia

Related Links

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https://www.angiolsurgery.org/magazine/2022/3/

ARTERIAL HYPERTENSION AFTER CAROTID ENDARTERECTOMY AND INTERNAL CAROTID ARTERY STENTING

Other Identifiers

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Hypertension_after_CEA_or_CAS

Identifier Type: -

Identifier Source: org_study_id