NCT04431609

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
2mo left

Started Jun 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress98%
Jun 2019Jun 2026

Study Start

First participant enrolled

June 19, 2019

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 30, 2020

Completed
5 months until next milestone

First Posted

Study publicly available on registry

June 16, 2020

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Last Updated

October 6, 2023

Status Verified

October 1, 2023

Enrollment Period

7 years

First QC Date

January 30, 2020

Last Update Submit

October 5, 2023

Conditions

Keywords

Carotid WebCerebral InfarctionCohort

Outcome Measures

Primary Outcomes (1)

  • Number of patients included and validated by the expert committee at the end of the inclusion period

    The missing data concerning clinical data, therapy used and functional prognosis between 3 and 6 months should be \<10%. Each item entered in the eCRF can be answered. The lack of response will be considered as missing data in the patient's file.

    At 3 years

Secondary Outcomes (9)

  • Demographics collected at the inclusion

    at the inclusion

  • NIHSS score at the admission in the neurological unit

    at the inclusion

  • Radiological of the cerebral infarction collected at the inclusion

    Web measurements carried out by 2 experts one month after the inclusion

  • Radiological of the cerebral infarction collected one month after the inclusion

    Web measurements carried out by 2 experts one month after the inclusion

  • Management of the cerebral infarction in emergency (within 48 hours from stroke onset): Thrombolysis, Thrombectomy, Decompressive hemicraniectomy, Antiplatelet or Anticoagulant treatment

    at the inclusion

  • +4 more secondary outcomes

Study Arms (1)

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.

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients over 18 years of age, with imagery available by Angioscanner, Angio-MRI, or arteriography and revealing the presence of a carotid web, with a cerebral infarction or transient ischemic attack in the carotid territory downstream of a lesion of carotid web viewed on a brain MRI.

You may qualify if:

  • 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

You may not qualify if:

  • Age \<18 years
  • Patient expressing opposition to be enrolled in the CAROWEB cohort

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Bordeaux

Bordeaux, 33076, France

RECRUITING

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Cerebral Infarction

Condition Hierarchy (Ancestors)

Brain InfarctionBrain IschemiaCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesStrokeVascular DiseasesCardiovascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2020

First Posted

June 16, 2020

Study Start

June 19, 2019

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2026

Last Updated

October 6, 2023

Record last verified: 2023-10

Locations