Carotid StenosisNCT06756360
Efficacy and Outcome of Carotid Endarterectomy for Symptomatic Carotid Stenosis
An observational study of Carotid Stenosis, run by Assiut University.
Trial summary
Neurovascular complications can result from this procedure usually from thromboembolism from the operated vessel, cerebral hypoperfusion causing ischaemia and, rarely, intracerebral haemorrhage. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carotid Stenosis
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2025to 1 Mar 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Symptomatic carotid artery stenosis with Carotid artery stenosis more than 60 %
Who may be able to join
- • Symptomatic carotid artery stenosis
- Carotid artery stenosis more than 60 %
Who cannot join
- Patient with other etiology (vasculitis dissection)
- Patient with mild Stenosis
- Asymptomatic
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Neurovascular complications can result from this procedure usually from thromboembolism from the operated vessel, cerebral hypoperfusion causing ischaemia and, rarely, intracerebral haemorrhage. The overall incidence of perioperative strokes complicating CEA is approximately 4% ,and represents a devastating outcome that the procedure was designed to prevent. Other neurological sequelae complicating carotid revascularisation include cerebral hyperperfusion syndrome, cranial and peripheral nerve injuries, and contrast encephalopathy in patients undergoing CAS.
The aim of this study is To evaluate the safety and efficacy of carotid endarterectomy for symptomatic carotid Stenosis patients
Read the detailed description
Carotid stenosis, a condition characterized by the narrowing of the carotid arteries, is a significant concern due to its potential to cause debilitating strokes. As individuals age, the prevalence of moderate to severe carotid artery stenosis increases, particularly after the age of 50, and it affects men more than women. When a physician detects the presence of carotid bruit, an ultrasound examination or CTA/MRA is typically prescribed to confirm the presence and severity of carotid stenosis .
Carotid artery stenosis (CAS) is characterized by the thickening of the arterial walls due to the formation of atherosclerotic plaque, leading to a reduction in the diameter of the artery. The arterial structure is composed of three layers of tissue: tunica intima, tunica media, and tunica adventitia. The tunica intima, which contains a monolayer of endothelial cells, plays a crucial role in facilitating blood movement. In response to injury, the endothelium triggers a biochemical signal for inflammatory cell migration, leading to the formation of fatty streaks and subsequently atherosclerotic plaque. Various factors such as hemodynamic, metabolic, environmental, and genetic risks contribute to inflammatory responses, cell proliferation, and plaque progression. The formation of atheroma in the arterial lumen ultimately results in arterial stenosis, which can lead to transient ischemic attack (TIA) or stroke .
The management of carotid stenosis involves two main interventions: carotid endarterectomy (CEA) and carotid artery stenting (CAS). CEA is a surgical procedure that entails the removal of atherosclerotic material causing stenosis at the carotid bifurcation. It can be performed under local or general anesthesia, with local anesthesia offering the advantage of enabling direct observation and monitoring of the patient's neurological status throughout the procedure. On the other hand, CAS is often carried out under local anesthesia and involves the placement of a stent across the stenosis to restore the normal luminal diameter. Prior to these interventions, patients are typically prescribed lipid-lowering and antithrombotic medications to stabilize the plaque and discourage thrombosis. The indications for CEA and CAS are similar, with considerations for both symptomatic and asymptomatic patients based on the degree of stenosis and the perceived long-term risk of stroke .
. Stroke is prevalent ailment that impacts a substantial number of individuals globally, resulting in both physical impairment and mortality. One of its major causes is carotid artery stenosis. The symptoms and degree of stenosis are key indications for carotid endarterectomy (CEA). In this study, we highlight the indications and outcomes of carotid endarterectomy .
Carotid endarterectomy (CEA) is known to reduce stroke risk in patients with symptomatic, moderate to severe carotid stenosis but has no apparent impact in patients with symptomatic, mild (less than 50%) carotid stenosis. However, recent development of noninvasive imaging modalities has shown that a certain subgroup of patients are at high risk for further ischemic events despite antiplatelet therapy. This study, therefore, aimed to clarify the patients' clinical features and explore the impact of CEA for them.
Carotid artery stenting is an alternative to carotid endarterectomy for the treatment of atherosclerotic carotid artery stenosis.
- Conditions
- Carotid Stenosis
- Keywords
- carotid endarterectomy
- Medical subject headings
- Carotid Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| carotid artery stenosis patient | patients will subjected to Preoperative Carotid doppler - CT angiography Postoperative carotid doppler-CT angiography after 3 days |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of post operative ipsilateral stroke
rate of post operative ipsilateral stroke
Measured: 30 day
mortality rate
short term mortality rate postoperative
Measured: 30 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2025
- Study start1 Jan 2025 (estimated)
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Carotid StenosisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Helal sayed ali, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06756360
- Sponsor's protocol ID
- carotid endarterectomy
- Status last verified
- Jan 2025
- First submitted
- 17 Dec 2024
- Last updated
- 3 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Saxena A, Ng EYK, Lim ST. Imaging modalities to diagnose carotid artery stenosis: progress and prospect. Biomed Eng Online. 2019 May 28;18(1):66. doi: 10.1186/s12938-019-0685-7.
PubMed 31138235
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Outcome of Carotid Endarterectomy for Symptomatic Carotid Stenosis
- ClinicalTrials.gov ID
- NCT06756360
- Acronym / sponsor ID
- carotid endarterectomy
- Conditions
- Carotid Stenosis
- Keywords
- carotid endarterectomy
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 3 Jan 2025 (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.
Neurovascular complications can result from this procedure usually from thromboembolism from the operated vessel, cerebral hypoperfusion causing ischaemia and, rarely, intracerebral haemorrhage. The overall incidence of perioperative strokes complicating CEA is approximately 4% ,and represents a devastating outcome that the procedure was designed to prevent. Other neurological sequelae complicating carotid revascularisation include cerebral hyperperfusion syndrome, cranial and peripheral nerve injuries, and contrast encephalopathy in patients undergoing CAS.
The aim of this study is To evaluate the safety and efficacy of carotid endarterectomy for symptomatic carotid Stenosis patients
Detailed description
Carotid stenosis, a condition characterized by the narrowing of the carotid arteries, is a significant concern due to its potential to cause debilitating strokes. As individuals age, the prevalence of moderate to severe carotid artery stenosis increases, particularly after the age of 50, and it affects men more than women. When a physician detects the presence of carotid bruit, an ultrasound examination or CTA/MRA is typically prescribed to confirm the presence and severity of carotid stenosis .
Carotid artery stenosis (CAS) is characterized by the thickening of the arterial walls due to the formation of atherosclerotic plaque, leading to a reduction in the diameter of the artery. The arterial structure is composed of three layers of tissue: tunica intima, tunica media, and tunica adventitia. The tunica intima, which contains a monolayer of endothelial cells, plays a crucial role in facilitating blood movement. In response to injury, the endothelium triggers a biochemical signal for inflammatory cell migration, leading to the formation of fatty streaks and subsequently atherosclerotic plaque. Various factors such as hemodynamic, metabolic, environmental, and genetic risks contribute to inflammatory responses, cell proliferation, and plaque progression. The formation of atheroma in the arterial lumen ultimately results in arterial stenosis, which can lead to transient ischemic attack (TIA) or stroke .
The management of carotid stenosis involves two main interventions: carotid endarterectomy (CEA) and carotid artery stenting (CAS). CEA is a surgical procedure that entails the removal of atherosclerotic material causing stenosis at the carotid bifurcation. It can be performed under local or general anesthesia, with local anesthesia offering the advantage of enabling direct observation and monitoring of the patient's neurological status throughout the procedure. On the other hand, CAS is often carried out under local anesthesia and involves the placement of a stent across the stenosis to restore the normal luminal diameter. Prior to these interventions, patients are typically prescribed lipid-lowering and antithrombotic medications to stabilize the plaque and discourage thrombosis. The indications for CEA and CAS are similar, with considerations for both symptomatic and asymptomatic patients based on the degree of stenosis and the perceived long-term risk of stroke .
. Stroke is prevalent ailment that impacts a substantial number of individuals globally, resulting in both physical impairment and mortality. One of its major causes is carotid artery stenosis. The symptoms and degree of stenosis are key indications for carotid endarterectomy (CEA). In this study, we highlight the indications and outcomes of carotid endarterectomy .
Carotid endarterectomy (CEA) is known to reduce stroke risk in patients with symptomatic, moderate to severe carotid stenosis but has no apparent impact in patients with symptomatic, mild (less than 50%) carotid stenosis. However, recent development of noninvasive imaging modalities has shown that a certain subgroup of patients are at high risk for further ischemic events despite antiplatelet therapy. This study, therefore, aimed to clarify the patients' clinical features and explore the impact of CEA for them.
Carotid artery stenting is an alternative to carotid endarterectomy for the treatment of atherosclerotic carotid artery stenosis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| carotid artery stenosis patient | – | –patients will subjected to Preoperative Carotid doppler - CT angiography Postoperative carotid doppler-CT angiography after 3 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Symptomatic carotid artery stenosis with Carotid artery stenosis more than 60 %
Key inclusion criteria (2 listed)
- • Symptomatic carotid artery stenosis
Key exclusion criteria (3 listed)
- Patient with other etiology (vasculitis dissection)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
rate of post operative ipsilateral stroke
Time frame: 30 day
rate of post operative ipsilateral stroke
mortality rate
Time frame: 30 day
short term mortality rate postoperative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2025.
- Results publication: PubMed 31138235Saxena A, Ng EYK, Lim ST. Imaging modalities to diagnose carotid artery stenosis: progress and prospect. Biomed Eng Online. 2019 May 28;18(1):66. doi: 10.1186/s12938-019-0685-7.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Carotid Stenosis, run by Assiut University.
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 2 inclusion and 3 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: opening soon, as of the sponsor's last update on 3 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Helal sayed Ali, resident doctor (01128674297, symd2030@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rate of post operative ipsilateral stroke (time frame: 30 day). The study lists 2 primary outcomes in all. 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 NCT06756360, which also lists 1 linked publication.
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 3 Jan 2025.