NCT06207643

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2024

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 31, 2023

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 17, 2024

Completed
15 days until next milestone

Study Start

First participant enrolled

February 1, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2025

Completed
Last Updated

January 17, 2024

Status Verified

January 1, 2024

Enrollment Period

8 months

First QC Date

December 31, 2023

Last Update Submit

January 12, 2024

Conditions

Carotid StenosisCarotid AtherosclerosisCarotid Artery Plaque

Keywords

carotid endarterectomy

Outcome Measures

Primary Outcomes (1)

  • postoperative immediate and short term complications

    occurrence of cerebrovascular stroke

    4 weeks postoperative following end of hospital dismiss

Study Arms (2)

group (A) conventional CEA

ACTIVE COMPARATOR

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

Procedure: carotid endarterectomy

group (B) Eversion CEA

ACTIVE COMPARATOR

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

Procedure: carotid endarterectomy

Interventions

carotid endarterectomyPROCEDURE

removing carotid artery atheromatous plaque surgically

group (A) conventional CEAgroup (B) Eversion CEA

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag University

Sohag, Egypt

RECRUITING

Related Publications (2)

  • 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.

    PMID: 32918282BACKGROUND

  • 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.

    PMID: 32801277BACKGROUND

MeSH Terms

Conditions

Carotid StenosisCarotid Artery Diseases

Interventions

Endarterectomy, Carotid

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

EndarterectomyVascular Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • kariem Mohamed

    sohag faculty of medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

kariem Ay Mohamed

CONTACT

+201010455201kareem.mahmoud@med.sohag.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant lecturer of vascular surgery Sohag university

Study Record Dates

First Submitted

December 31, 2023

First Posted

January 17, 2024

Study Start

February 1, 2024

Primary Completion

October 1, 2024

Study Completion

February 1, 2025

Last Updated

January 17, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)