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

NCT05931003 | Active Not Recruiting DMC

• 1 other identifier: Hypertension_after_CEA_or_CAS
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension; Carotid Stenosis; Symptomatic Carotid Artery Stenosis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change the degree of arterial hypertension

  Using ambulatory blood pressure monitoring (mmHg)

  2 years

Study Arms (2)

Carotid artery stenting

EXPERIMENTAL

Carotid artery stenting

Procedure: Carotid stenting

Carotid endarterectomy

ACTIVE COMPARATOR

Carotid endarterectomy

Procedure: Carotid endarterectomy

Interventions

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 artery stenting

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.

Carotid endarterectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Presence of symptomatic ICA stenosis 70-90%
• Arterial hypertension of 2 or 3 degrees
• CEA operation with carotid glomus removal or ICA stenting operation

You may not qualify if:

• 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

Sponsors & Collaborators

• Samara State Medical University: lead

Study Sites (1)

Samara State Medical University

Samara, Russia

Location

Related Links

• ARTERIAL HYPERTENSION AFTER CAROTID ENDARTERECTOMY AND INTERNAL CAROTID ARTERY STENTING

MeSH Terms

Conditions

Hypertension; Carotid Stenosis

Interventions

Endarterectomy, Carotid

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Carotid Artery Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases

Intervention Hierarchy (Ancestors)

Endarterectomy; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2023
• First Posted: July 5, 2023
• Study Start: July 1, 2022
• Primary Completion: September 1, 2024
• Study Completion (Estimated): September 1, 2026
• Last Updated: December 16, 2024

Record last verified: 2024-12

Locations

RU (1)