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

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

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05931003
Enrollment
90
Registered
2023-07-05
Start date
2022-07-01
Completion date
2026-09-01
Last updated
2024-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carotid Stenosis, Hypertension, Symptomatic Carotid Artery Stenosis

Keywords

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

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.

Interventions

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.

PROCEDURECarotid 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.

Sponsors

Samara State Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change the degree of arterial hypertension2 yearsUsing ambulatory blood pressure monitoring (mmHg)

Countries

Russia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026