Regional Strategy for Transfer for Mechanical Thrombectomy

Stroke Clinical Trial

— START  

Official title:

Strategy for Transfer to Emergency Head And Neck (UTEC) of Stroke Alerts With Suspicion of Large Vessel Occlusion for Mechanical Thrombectomy in the Languedoc Roussillon Region

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04046757
• Other study ID #: RECHMPL17_0378
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Ischemic
• Large Vessel Occlusion
• Stroke

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