Ignite Creation Date:
2024-05-06 @ 7:58 PM
Last Modification Date:
2024-10-26 @ 3:18 PM
Study NCT ID:
NCT06207643
Status:
RECRUITING
Last Update Posted:
2024-01-17
First Post:
2023-12-31
Brief Title:
Comparison Between Different Techniques for Carotid Artery Endarterectomy
Sponsor:
Sohag University
Organization:
Sohag University
Study Overview
Official Title:
Conventional Vs Eversion Carotid Endarterectomy Immediate and Short-Term Outcomes
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Its 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
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 Its 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None