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

Not Applicable

Active, not recruiting

• Conditions: Hypertension; Carotid Stenosis; Symptomatic Carotid Artery Stenosis
• Interventions: Procedure: Carotid stenting; Procedure: Carotid endarterectomy

• Registration Number: NCT05931003
• Lead Sponsor: Samara State Medical University

Brief Summary

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

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.

Study Timeline

• Study Start: 2022-07-01
• Study First Submitted: 2023-04-15
• Study First Submitted QC: 2023-06-29
• Study First Posted: 2023-07-05
• Primary Completion: 2024-09-01
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-11
• Last Update Posted: 2024-12-16
• Study Completion: 2026-09-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Carotid artery stenting	Carotid stenting	Carotid artery stenting
Carotid endarterectomy	Carotid endarterectomy	Carotid endarterectomy

Primary Outcome Measures

Name	Time	Method
Change the degree of arterial hypertension	2 years	Using ambulatory blood pressure monitoring (mmHg)

Trial Locations

Locations (1)

Samara State Medical University; 🇷🇺 Samara, Russian Federation