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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04046757
Other study ID # RECHMPL17_0378
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 1, 2019
Est. completion date June 2022

Study information

Verified date December 2021
Source University Hospital, Montpellier
Contact Caroline ARQUIZAN, MD
Phone 4 67 33 72 33
Email c-arquizan@chu-montpellier.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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


Description:

Multiple RCT has recently proved the superiority of mechanical thrombectomy compared to the best medical therapy (BMT) on patients with recent cerebral infarct and anterior circulation intracranial large vessel occlusion. In the Occitanie-Est region (ex Languedoc Roussillon), comprising 6 Stroke Unit, only the Comprehensive Stroke Unit of the CHU de Montpellier has a centre of interventional neuroradiology (NRI) that can perform mechanical thrombectomy. Patients suspected of stroke are referred to the nearest SU, then the candidates for thrombectomy, are transferred secondarily to the Stroke Center in Montpellier. Currently, there is no evidence that an initial management in a proximity stroke unit and a secondary transfer for a mechanical thrombectomy is associated with a loss of chance for patients, compared to patients initially treated at the Stroke Center regional reference. The objective of the study is to compare clinical outcome on patients admitted first in the Comprehensive Stroke Center of Montpellier those transferred after Proximity Stroke Unit or directly admitted when high suspicion of large vessel occlusion.


Recruitment information / eligibility

Status Recruiting
Enrollment 1200
Est. completion date June 2022
Est. primary completion date June 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility Inclusion Criteria: 1. Patient, admitted to the Emergency Department Head and Neck of the CHU de Montpellier, over 18 years old, without limit of upper age 2. With TIA or cerebral infarction (confirmed by brain imaging (MRI or CT scan), acute (Time of stroke symptoms or discovery of patient = 12 h) 3. With anterior circulation intracranial large vessel occlusion (M1, T or proximal M2), confirmed by arterial imaging (magnetic resonance angiography-MRA- or angioscanner) 4. No objection of the patient or their representative to being included in the cohort Exclusion Criteria: 1. Patient with severe intercurrent pathology impacting the short-term vital prognosis and making follow-up impossible 2. Predictable impossibility of patient follow-up

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Mechanical thrombectomy
Neuroradiological endovascular treatment

Locations

Country Name City State
France Gui De Chauliac Hospital Montpellier

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Incidence of mechanical thrombectomy treatment Safety of medical complication
Complications of mechanical thrombectomy :
Vessel perforation
Intramural Arterial dissection
Symptomatic Intracerebral hemorrhage
embolization to a new territory
24 hours
Secondary Clinical evolution at 24 hours NIHSS scale and NIHSS scale variation between the inclusion at 24 hours
National Institutes of Health Stroke Scale (NIHSS). Range 0-42. Neurological severity score at the acute phase :
Minor stroke : 0 to 5
Moderate stroke 6 to 20
Severe stroke up to 21
24 hours
Secondary Clinical evolution 7 days NIHSS scale and NIHSS scale variation between the inclusion at 7 days
National Institutes of Health Stroke Scale (NIHSS). Range 0-42. Neurological severity score at the acute phase :
Minor stroke : 0 to 5
Moderate stroke 6 to 20
Severe stroke up to 21
7 days
Secondary Proportion of patients having had mechanical trombectomy (and/or intravenous thrombolysis) amongst patient cohort. Number of patients having had mechanical trombectomy (and/or intravenous thrombolysis) amongst patient cohort. 24 hours
Secondary Symptomatic Intracerebral Haemorrhage symptomatic Intracerebral Haemorrhage on cerebral imaging at 24 hours 24 hours
Secondary Arterial Recanalisation with TICI score Quality of revascularization after mechanical thrombectomy : immediate post-Mechanical-Trombectomy evaluation for patient having had mechanical thrombectomy and at 24 hours for all patient cohort.
TICI score (Thrombolysis In Cerebral Infarction grading system) describe the quality of revascularization after mechanical thrombectomy (Grade 0 for no perfusion at 3 for Complete perfusion)
post-act / 24 hours
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