Carotid StenosisNCT06207643
Comparison Between Different Techniques for Carotid Artery Endarterectomy
A study testing carotid endarterectomy in people with Carotid Stenosis and Carotid Atherosclerosis, run by Sohag University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Carotid Stenosis, Carotid Atherosclerosis, Carotid Artery Plaque
- What is being tested?
- carotid endarterectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- Feb 2024to Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Conventional Vs. Eversion Carotid Endarterectomy Immediate and Short-Term Outcomes
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
Read the 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.
- Being tested
- carotid endarterectomy
- Keywords
- carotid endarterectomy
- Medical subject headings
- Carotid Stenosis, Carotid Artery Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
carotid endarterectomyProcedure or surgery
removing carotid artery atheromatous plaque surgically
| Study group | Role | What they receive |
|---|---|---|
| group (A) conventional CEA | Active comparator | this group of patients will be subjected to carotid endarterectomy using the conventional technique of this procedure Receives: 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 Receives: Procedure: carotid endarterectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative immediate and short term complications
occurrence of cerebrovascular stroke
Measured: 4 weeks postoperative following end of hospital dismiss
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2024
- Study startFeb 2024 (estimated)
- Primary completionOct 2024 (estimated)
- Study completionFeb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Carotid StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kariem Ayman Mohamed, Sohag University
- Investigators
- kariem Mohamed, Principal investigator, sohag faculty of medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06207643
- Sponsor's protocol ID
- Soh-Med-23-12-01MD
- Status last verified
- Jan 2024
- First submitted
- 31 Dec 2023
- Last updated
- 17 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32918282Uno 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.
PubMed 32801277
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conventional Vs. Eversion Carotid Endarterectomy Immediate and Short-Term Outcomes
- ClinicalTrials.gov ID
- NCT06207643
- Acronym / sponsor ID
- Soh-Med-23-12-01MD
- Keywords
- carotid endarterectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- Feb 2024 (estimated)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Feb 2025 (estimated)
- First posted
- 17 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group (A) conventional CEA | Active comparator | Procedure: carotid endarterectomythis group of patients will be subjected to carotid endarterectomy using the conventional technique of this procedure |
| group (B) Eversion CEA | Active comparator | Procedure: carotid endarterectomythis group of patients will be subjected to carotid endarterectomy using the Eversion technique of this procedure |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| carotid endarterectomyremoving carotid artery atheromatous plaque surgically | Procedure or surgery | group (A) conventional CEA, group (B) Eversion CEA |
Primary outcome
postoperative immediate and short term complications
Time frame: 4 weeks postoperative following end of hospital dismiss
occurrence of cerebrovascular stroke
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2024.
- Background: PubMed 32918282Rerkasem 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.
- Background: PubMed 32801277Uno 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
kariem Mohamed principal investigator
sohag faculty of medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing carotid endarterectomy in people with Carotid Stenosis and Carotid Atherosclerosis, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact kariem Ay Mohamed (+201010455201, kareem.mahmoud@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative immediate and short term complications (time frame: 4 weeks postoperative following end of hospital dismiss). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06207643, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2024.