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AzTrials

Carotid StenosisNCT06756360

Efficacy and Outcome of Carotid Endarterectomy for Symptomatic Carotid Stenosis

An observational study of Carotid Stenosis, run by Assiut University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

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.

Helal sayed Ali, resident doctor contact

01128674297

symd2030@gmail.com

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.

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 groups in NCT06756360
Study groupRoleWhat they receive
carotid artery stenosis patientpatients 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.

  1. rate of post operative ipsilateral stroke

    rate of post operative ipsilateral stroke

    Measured: 30 day

  2. 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.

  1. First posted3 Jan 2025
  2. Study start1 Jan 2025 (estimated)
  3. Primary completion1 Jan 2026 (estimated)
  4. Study completion1 Mar 2026 (estimated)

Resources

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)
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

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.

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