Carotid Web Associated With Cerebral Infarctions

NCT ID: NCT04431609

Last Updated: 2023-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-06-19

Study Completion Date

2026-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Carotid Web located at the bulb level is a rare condition and is often associated with severe cerebral infarction in the carotid territory. This condition has been described predominantly in the black population. However, limited data are available for the epidemiology of carotid web and often result from selected population studies. It has been shown that the carotid web is a focal intimal dysplasia. Rate of ischemic stroke recurrence is high, even in patients treated with antiplatelet therapy. This subtle lesion is often unknown and misdiagnosed including in stroke unit. We assume that the implementation of a multicentric cohort would allow a comprehensive analysis of the carotid web condition.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Carotid web lesions associated with cerebral infarctions are a relatively rare and largely unknown disease. However, carotid web lesions are associated with severe infarction involving the functional and vital prognosis of patients. The high rate of recurrence should lead to an identification of the lesion at the first event in order to propose a suitable preventive treatment. We believe that only a multicenter cohort will be able to analyze the characteristics of the pathology and propose studies on critical size samples. A national cohort would lead quickly to a consequent collection of cases. By including overseas departments and communities, notions of prevalence and characteristics within different populations could finally be studied. Participation to the cohort constitution will probably lead to sensitizing the various actors of the course of stroke care to the diagnosis and appropriate care of the carotid web.

Patients will be selected by the Stroke Units which take part in the cohort constitution. Stroke Unit investigator will fill the WEPI online entry database. Clinical, imaging and outcome characteristics will be informed.

In order to guarantee the quality of the cases collected, the validation of the carotid web lesion will be carried out by a pair of expert Neurologist - Neuroradiologist appointed within an expert committee. In case of no consensus, a third expert will resolve the disagreement.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Carotid Arteries

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

CAROtid WEB associated with cerebral infarction

french multicentric cohort that collects retrospectively and prospectively purely observational data on patients with cerebral infarction associated with a carotid web. Diagnostic, therapeutic or follow-up strategies will be at the discretion of the Stroke Unit taking care of the patient.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Age ≥18 years
* Available imaging revealing the presence of a carotid web
* Cerebral infarction or transient ischemic attack in the carotid area downstream of a carotid web lesion.
* Validation of the carotid web by a pair of experts Neurologist and Neuroradiologist
* Agreement of the patient or the support person given after reading the information and non-opposition form

Exclusion Criteria

* Age \<18 years
* Patient expressing opposition to be enrolled in the CAROWEB cohort
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital, Bordeaux

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

CHU de Bordeaux

Bordeaux, , France

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

France

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Stéphane OLINDO, M.D

Role: CONTACT

05 57 82 12 63

Aurore CAPELLI, PhD

Role: CONTACT

05 57 82 08 77

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Stéphane OLINDO, MD

Role: primary

05 57 82 12 63

References

Explore related publications, articles, or registry entries linked to this study.

Poirette P, Chausson N, Papaxanthos J, Kyheng M, Labreuche J, Smadja D, Gaillard N, Signate A, Joux J, Obadia M, Renou P, Boyer A, Desilles JP, Boulanger M, Robinet-Borgomano E, Zhu F, Richard S, Turpinat C, Landais A, Desal H, Guillon B, Viguier A, Lamy M, Denier C, Lecluse A, Malrain C, Lyoubi A, Holay Q, Bourgeois Q, Chaari D, Olindo S, Marnat G; CAROWEB Investigators. Delay in Carotid Web Diagnosis Remains Common and Associated With an Increased Risk of Stroke Recurrence. Stroke. 2025 Aug;56(8):2091-2100. doi: 10.1161/STROKEAHA.124.050238. Epub 2025 May 12.

Reference Type DERIVED
PMID: 40351183 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CHUBX 2018/40

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Neurothrombectomy France
NCT02880579 COMPLETED
Natural History Study of CADASIL
NCT05072483 RECRUITING
Dijon Stroke Cohort
NCT04489199 RECRUITING
Vein of Galen Aneurysm
NCT06595264 COMPLETED