Reconstruction of the Carotid Bifurcation in Patients With Arterial Hypertension of 2-3 Degrees
Primary Purpose
Hypertension, Carotid Stenosis, Symptomatic Carotid Artery Stenosis
Status
Recruiting
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
Carotid stenting
Carotid endarterectomy
Sponsored by
About this trial
This is an interventional treatment trial for Hypertension focused on measuring Hypertension, Carotid Stenosis, Symptomatic Carotid Artery Stenosis, Glomus ectomy
Eligibility Criteria
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
Sites / Locations
- Samara State Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Carotid artery stenting
Carotid endarterectomy
Arm Description
Carotid artery stenting
Carotid endarterectomy
Outcomes
Primary Outcome Measures
Change the degree of arterial hypertension
Using ambulatory blood pressure monitoring (mmHg)
Secondary Outcome Measures
Full Information
NCT ID
NCT05931003
First Posted
April 15, 2023
Last Updated
June 29, 2023
Sponsor
Samara State Medical University
1. Study Identification
Unique Protocol Identification Number
NCT05931003
Brief Title
Reconstruction of the Carotid Bifurcation in Patients With Arterial Hypertension of 2-3 Degrees
Official Title
Reconstruction of the Carotid Bifurcation in Patients With Arterial Hypertension of 2-3 Degrees
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2022 (Actual)
Primary Completion Date
September 1, 2023 (Anticipated)
Study Completion Date
September 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Samara State Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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:
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Carotid Stenosis, Symptomatic Carotid Artery Stenosis
Keywords
Hypertension, Carotid Stenosis, Symptomatic Carotid Artery Stenosis, Glomus ectomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
112 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Carotid artery stenting
Arm Type
Experimental
Arm Description
Carotid artery stenting
Arm Title
Carotid endarterectomy
Arm Type
Active Comparator
Arm Description
Carotid endarterectomy
Intervention Type
Procedure
Intervention Name(s)
Carotid stenting
Intervention Description
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
Intervention Name(s)
Carotid endarterectomy
Intervention Description
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 Outcome Measure Information:
Title
Change the degree of arterial hypertension
Description
Using ambulatory blood pressure monitoring (mmHg)
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vachev Alexey, DM
Phone
+79198012662
Email
a.n.vachjov@samsmu.ru
First Name & Middle Initial & Last Name or Official Title & Degree
Sevriukova Viktoriia
Phone
+79878184838
Email
vika_s24@mail.ru
Facility Information:
Facility Name
Samara State Medical University
City
Samara
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vachev Alexey, DM
Phone
+79198012662
Email
a.n.vachjov@samsmu.ru
First Name & Middle Initial & Last Name & Degree
Sevriukova Viktoriia
Phone
+79878184838
Email
vika_s24@mail.ru
12. IPD Sharing Statement
Links:
URL
https://www.angiolsurgery.org/magazine/2022/3/
Description
ARTERIAL HYPERTENSION AFTER CAROTID ENDARTERECTOMY AND INTERNAL CAROTID ARTERY STENTING
Learn more about this trial
Reconstruction of the Carotid Bifurcation in Patients With Arterial Hypertension of 2-3 Degrees
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