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

Sponsor
Samara State Medical University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05931003
Collaborator
(none)
112
1
2
38
2.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Carotid stenting
  • Procedure: Carotid endarterectomy
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
112 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Reconstruction of the Carotid Bifurcation in Patients With Arterial Hypertension of 2-3 Degrees
Actual Study Start Date :
Jul 1, 2022
Anticipated Primary Completion Date :
Sep 1, 2023
Anticipated Study Completion Date :
Sep 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Carotid artery stenting

Carotid artery stenting

Procedure: 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.

Active Comparator: Carotid endarterectomy

Carotid endarterectomy

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.

Outcome Measures

Primary Outcome Measures

  1. Change the degree of arterial hypertension [1 year]

    Using ambulatory blood pressure monitoring (mmHg)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Samara State Medical University Samara Russian Federation

Sponsors and Collaborators

  • Samara State Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Samara State Medical University
ClinicalTrials.gov Identifier:
NCT05931003
Other Study ID Numbers:
  • Hypertension_after_CEA_or_CAS
First Posted:
Jul 5, 2023
Last Update Posted:
Jul 5, 2023
Last Verified:
Jun 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Samara State Medical University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 5, 2023