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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Hypertension Arterial Occlusive Diseases Brain Diseases Cardiovascular Diseases Carotid Artery Diseases Carotid Stenosis Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Symptomatic Carotid Artery Stenosis Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Samara State Medical University

Samara, Russia

About this study

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:

To study the course of hypertension after carotid endarterectomy with removal of the carotid glomus.
To study the course of hypertension in patients after stenting of the internal carotid artery.
To substantiate the strategy for performing carotid endarterectomy in patients with bilateral significant lesions of the internal carotid artery.
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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Carotid stenting

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

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.

Primary outcomes

Change the degree of arterial hypertension

Time frame: 2 years

Using ambulatory blood pressure monitoring (mmHg)

Sponsors and collaborators

Lead sponsor

Samara State Medical University

Other

Registry information

Important dates

Study start: 2022
Primary completion: 2024
Study completion: 2026
First posted: Jul 5, 2023
Registry last updated: Dec 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed