Carotid ArteriesCAROWEBNCT04431609
Carotid Web Associated With Cerebral Infarctions
An observational study of Carotid Arteries, run by University Hospital, Bordeaux at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carotid Arteries
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- 19 Jun 2019to 30 Jun 2026
- How long will I take part?
- 3 Years
- Phase
- Observational
- 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 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Age <18 years
- Patient expressing opposition to be enrolled in the CAROWEB cohort
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU de Bordeaux
Bordeaux, 33076
Stéphane OLINDO, MD, 05 57 82 12 63, stephane.olindo@chu-bordeaux.fr
About this study
Official title: French Cohort of Carotid Web Associated With Cerebral Infarctions
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.
Read the detailed description
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
- Carotid Arteries
- Keywords
- Carotid Web, Cerebral Infarction, Cohort
- Medical subject headings
- Cerebral Infarction
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 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 3 years
Secondary outcomes (9)
Demographics collected at the inclusion
Age, Sex, Ethnic group based on self-determination
Measured: at the inclusion
NIHSS score at the admission in the neurological unit
NIHSS scale (National Institute of Health Stroke Score) was described by T. Brott, in 1989, for used to assess patients with acute ischemic stroke. It can be used in carotid and vertebrobasilar ischemic attacks. The passing time of the scale is 6 minutes 30 on average. The NIHSS Score ranges from 0 to 42. A higher score indicates a worse clinical status.
Measured: at the inclusion
Radiological of the cerebral infarction collected at the inclusion
localization and extent of the infarction on the cerebral MRI and Radiological of the carotid Web: Uni or bilaterality,
Measured: Web measurements carried out by 2 experts one month after the inclusion
Radiological of the cerebral infarction collected one month after the inclusion
localization and extent of the infarction on the cerebral MRI and Radiological of the carotid Web: Uni or bilaterality,
Measured: 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
Number of patients treated with: 1) Thrombolysis, 2) Mechanical Thrombectomy, 3) Decompressive hemicraniectomy, 4) Antiplatelet treatment, 5) Anticoagulant treatment
Measured: at the inclusion
Secondary preventive strategies applied between 2 and 90 days after stroke onset:- Number of patients treated -
- Number of patients treated with: 1) Antiplatelet treatment alone, 2) Anticoagulant treatment alone, 3) Endarterectomy and excision of the Web, 4) Carotid artery stenting
Measured: at 3-month
Secondary preventive strategies applied between 2 and 90 days after stroke onset:- Percentage of intracerebral hemorrhage and major systemic bleeding in patients treated -
- Percentage of intracerebral hemorrhage and major systemic bleeding in patients treated with: 1) Antiplatelet treatment alone, 2) Anticoagulant treatment alone, 3) Endarterectomy and excision of the Web, 4) Carotid artery stenting
- Intracerebral hemorrhage has to be proven by a brain CT Scan or MRI.
- Major systemic bleeding is defined according to Schulman et al., Journal of thrombosis and haemostasis, 2005.
Measured: at 3-month
Stroke Outcome assessed with the Modified Rankin Scale score.
The Modified Rankin Scale (MRS) is a single item overall outcome assessment scale for post-stroke patients. It is used to categorize the level of functional independence based on pre-stroke activities rather than on observing performance while performing a specific task. A higher score (range from 0 to 6) indicates a poorer outcome.
Measured: Between 3 to 6 months
Incidence rates and delays of cerebrovascular events recurrence such as cerebral infarction or transient ischemic attack
Measured: From inclusion to the end of follow-up: 3 to 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2020
- Study start19 Jun 2019
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 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 ArteriesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04431609
- Sponsor's protocol ID
- CHUBX 2018/40
- Acronym
- CAROWEB
- Status last verified
- Oct 2023
- First submitted
- 30 Jan 2020
- Last updated
- 6 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40351183
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- French Cohort of Carotid Web Associated With Cerebral Infarctions
- ClinicalTrials.gov ID
- NCT04431609
- Acronym / sponsor ID
- CAROWEB / CHUBX 2018/40
- Conditions
- Carotid Arteries
- Keywords
- Carotid Web, Cerebral Infarction, Cohort
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 19 Jun 2019 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 16 Jun 2020 (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.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Age <18 years
- Patient expressing opposition to be enrolled in the CAROWEB cohort
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
Number of patients included and validated by the expert committee at the end of the inclusion period
Time frame: At 3 years
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.
9 secondary outcomes
Demographics collected at the inclusion
Time frame: at the inclusion
NIHSS score at the admission in the neurological unit
Time frame: at the inclusion
Radiological of the cerebral infarction collected at the inclusion
Time frame: Web measurements carried out by 2 experts one month after the inclusion
Radiological of the cerebral infarction collected one month after the inclusion
Time frame: 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
Time frame: at the inclusion
Secondary preventive strategies applied between 2 and 90 days after stroke onset:- Number of patients treated -
Time frame: at 3-month
Secondary preventive strategies applied between 2 and 90 days after stroke onset:- Percentage of intracerebral hemorrhage and major systemic bleeding in patients treated -
Time frame: at 3-month
Stroke Outcome assessed with the Modified Rankin Scale score.
Time frame: Between 3 to 6 months
Incidence rates and delays of cerebrovascular events recurrence such as cerebral infarction or transient ischemic attack
Time frame: From inclusion to the end of follow-up: 3 to 6 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2023.
- Derived from this study: PubMed 40351183Poirette 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.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carotid Arteries, run by University Hospital, Bordeaux at 1 site in France.
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 5 inclusion and 2 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 6 Oct 2023. 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 France. 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 Stéphane OLINDO, M.D (05 57 82 12 63, stephane.olindo@chu-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients included and validated by the expert committee at the end of the inclusion period (time frame: At 3 years). 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 NCT04431609, 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 6 Oct 2023.