Comparison Between Different Techniques for Carotid Artery Endarterectomy

NCT ID: NCT06207643

Last Updated: 2024-01-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-29
• Study Completion Date: 2025-02-28

Brief Summary

the goal of this interventional study is to compare between the conventional and the Eversion techniques in performing carotid endarterectomy in patients with carotid artery stenosis the main question it aim to answer is which technique is much more safe and effective the participants will have carotid endarterectomy by one of the two techniques the researcher will compare the group subjected to conventional carotid endarterectomy and the group subjected to Eversion carotid endarterectomy to see which technique is more effective and safe

Detailed Description

Carotid endarterectomy (CEA) is widely recognized as the gold standard approach for the prevention of major cerebral events in patients with significant carotid stenosis as it is considered as cerebral revascularization. The procedure entails removing the plaque from the common carotid artery (CCA) and internal carotid artery (ICA) to improve blood flow, prevent potential embolic material and therefore restoring proper cerebral blood flow.

Carotid endarterectomy (CEA) has proven to be a safe and durable operation to decrease the risk of stroke in both symptomatic and asymptomatic patients with extracranial carotid artery stenosis. it is recommended for most symptomatic patients with 50%-99% ICA stenosis. It's considered for asymptomatic patients with 60% - 99%.

There are two main techniques of CEA, conventional carotid endarterectomy (C-CEA) and eversion carotid endarterectomy (E-CEA). More often used is conventional carotid endarterectomy (C-CEA) which is consists of a vertical arteriotomy begun on the CCA and continued through the carotid bifurcation into the ICA beyond the full length of the plaque and closure by patch angioplasty.

As regard comparison between (C-CEA) and (E-CEA) Several studies showed that C-CEA and E-CEA are equally effective surgical approaches for extracranial carotid occlusive disease and studies that compared the influence of E-CEA and C-CEA on postoperative results had varied conclusions some studies have reported no difference in restenosis rates while others have reported less restenosis in eversion endarterectomy. more studies are needed to approve such results, Therefore, it remains difficult to choose the optimal endarterectomy technique.

the study will include 40 patients divided into two groups 20 patients for each group, each group will be subjected to one technique to compare safety and efficacy of each one.

Conditions

Carotid Stenosis; Carotid Atherosclerosis; Carotid Artery Plaque

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

group (A) conventional CEA

this group of patients will be subjected to carotid endarterectomy using the conventional technique of this procedure

Group Type: ACTIVE_COMPARATOR

carotid endarterectomy

Intervention Type: PROCEDURE

removing carotid artery atheromatous plaque surgically

group (B) Eversion CEA

this group of patients will be subjected to carotid endarterectomy using the Eversion technique of this procedure

Group Type: ACTIVE_COMPARATOR

carotid endarterectomy

Intervention Type: PROCEDURE

removing carotid artery atheromatous plaque surgically

Interventions

carotid endarterectomy

removing carotid artery atheromatous plaque surgically

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Patients having carotid artery stenosis with cerebral events (recent stroke).
• Patients having high grade carotid artery stenosis with increasing symptoms.
• Patients underwent previously CEA presented with carotid restenosis.

Exclusion Criteria

• Non atherosclerotic carotid artery stenosis e.g., vasculitis, collagen vascular diseases and hypoplastic ICA.
• patients with recently thrombosed ICA.
• High carotid bifurcation to the extent makes CEA not accessible in easy or safe way e.g., increased risk of cranial nerve injury.
• acute ischemic stroke within less than 2 weeks before the procedure.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sohag University

OTHER

Sponsor Role: lead

Responsible Party

Kariem Ayman Mohamed

assistant lecturer of vascular surgery Sohag university

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

kariem Mohamed

Role: PRINCIPAL_INVESTIGATOR

sohag faculty of medicine

Locations

Sohag University

Sohag, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

kariem Ay Mohamed

Role: CONTACT

kareem.mahmoud@med.sohag.edu.eg

+201010455201

References

Rerkasem A, Orrapin S, Howard DP, Rerkasem K. Carotid endarterectomy for symptomatic carotid stenosis. Cochrane Database Syst Rev. 2020 Sep 12;9(9):CD001081. doi: 10.1002/14651858.CD001081.pub4.

Reference Type: BACKGROUND

PMID: 32918282 (View on PubMed)

Uno M, Takai H, Yagi K, Matsubara S. Surgical Technique for Carotid Endarterectomy: Current Methods and Problems. Neurol Med Chir (Tokyo). 2020 Sep 15;60(9):419-428. doi: 10.2176/nmc.ra.2020-0111. Epub 2020 Aug 15.

Reference Type: BACKGROUND

PMID: 32801277 (View on PubMed)

Other Identifiers

Soh-Med-23-12-01MD

Identifier Type: -

Identifier Source: org_study_id