Regional Strategy for Transfer for Mechanical Thrombectomy

NCT ID: NCT04046757

Last Updated: 2021-12-29

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 1200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-10-01
• Study Completion Date: 2022-06-30

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

Detailed 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.

Conditions

Stroke; Ischemic; Large Vessel Occlusion

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Mechanical thrombectomy

Neuroradiological endovascular treatment

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Montpellier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Caroline ARQUIZAN, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Montpellier

Locations

Gui De Chauliac Hospital

Montpellier, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Caroline ARQUIZAN, MD

Role: CONTACT

c-arquizan@chu-montpellier.fr

4 67 33 72 33

Jessica HATTINGUAIS, CRA

Role: CONTACT

j-hattinguais@chu-montpellier.fr

4 67 33 56 53 ext. +33

Facility Contacts

Caroline ARQUIZAN, MD

Role: primary

c-arquizan@chu-montpellier.fr

Other Identifiers

RECHMPL17_0378

Identifier Type: -

Identifier Source: org_study_id