NCT04046757

Brief Summary

A mono-centre observational study with the aim of compare clinical outcome at 3 month on patients admitted with recent cerebral infarct and intracranial large vessel occlusion in the anterior circulation who are eligible for mechanical thrombectomy in three different position : Patients admitted first in the Comprehensive Stroke Center of Montpellier, those transferred after Proximity Stroke Unit or prehospital bypass for patients with high suspicion of large vessel occlusion.to the Comprehensive Stroke Center of Montpellier

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 7, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 6, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2019

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

December 29, 2021

Status Verified

December 1, 2021

Enrollment Period

2.7 years

First QC Date

June 7, 2019

Last Update Submit

December 28, 2021

Conditions

Keywords

Ischemic strokeMechanical Thrombectomy

Outcome Measures

Primary Outcomes (1)

  • Modified Rankin Score (mRS)

    Good functional outcome ( defined by a Modified Rankin Scale of 0-2, 3 months after stroke onset Modified Rankin scale . Range 0 (asymptomatic) to 6 (death) * Good outcome : 0 to 2 * Disability : 3 to 5 * Bad outcome : 5 and 6

    3 months

Secondary Outcomes (6)

  • Incidence of mechanical thrombectomy treatment

    24 hours

  • Clinical evolution at 24 hours

    24 hours

  • Clinical evolution 7 days

    7 days

  • Proportion of patients having had mechanical trombectomy (and/or intravenous thrombolysis) amongst patient cohort.

    24 hours

  • Symptomatic Intracerebral Haemorrhage

    24 hours

  • +1 more secondary outcomes

Interventions

Neuroradiological endovascular treatment

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Acute cerebral infarct in the arterial circulation with large vessel occlusion

You may qualify if:

  • Patient, admitted to the Emergency Department Head and Neck of the CHU de Montpellier, over 18 years old, without limit of upper age
  • With TIA or cerebral infarction (confirmed by brain imaging (MRI or CT scan), acute (Time of stroke symptoms or discovery of patient ≤ 12 h)
  • With anterior circulation intracranial large vessel occlusion (M1, T or proximal M2), confirmed by arterial imaging (magnetic resonance angiography-MRA- or angioscanner)
  • No objection of the patient or their representative to being included in the cohort

You may not qualify if:

  • Patient with severe intercurrent pathology impacting the short-term vital prognosis and making follow-up impossible
  • Predictable impossibility of patient follow-up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gui De Chauliac Hospital

Montpellier, 34295, France

RECRUITING

MeSH Terms

Conditions

StrokeIschemiaIschemic Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Caroline ARQUIZAN, MD

    University Hospital, Montpellier

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Caroline ARQUIZAN, MD

CONTACT

Jessica HATTINGUAIS, CRA

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 7, 2019

First Posted

August 6, 2019

Study Start

October 1, 2019

Primary Completion

June 1, 2022

Study Completion

June 1, 2022

Last Updated

December 29, 2021

Record last verified: 2021-12

Locations