Regional Strategy for Transfer for Mechanical Thrombectomy (START)

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

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

Study Overview

• Status: Recruiting
• Conditions: Stroke; Large Vessel Occlusion; Ischemic
• Intervention / Treatment: Other: Mechanical thrombectomy

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.

• Study Type: Observational
• Enrollment (Anticipated): 1200

Contacts and Locations

• Study Contact: Name: Caroline ARQUIZAN, MD; Phone Number: 4 67 33 72 33; Email: c-arquizan@chu-montpellier.fr
• Study Contact Backup: Name: Jessica HATTINGUAIS, CRA; Phone Number: +33 4 67 33 56 53; Email: j-hattinguais@chu-montpellier.fr

Study Locations

• France
  • Montpellier, France, 34295
    • Recruiting
    • Gui de Chauliac Hospital
    • Contact: Caroline ARQUIZAN, MD; Phone Number: c-arquizan@chu-montpellier.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Acute cerebral infarct in the arterial circulation with large vessel occlusion

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
Symptomatic Intracerebral Haemorrhage	symptomatic Intracerebral Haemorrhage on cerebral imaging at 24 hours	24 hours
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

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Investigators: Principal Investigator: Caroline ARQUIZAN, MD, University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2019
• Primary Completion (Anticipated): June 1, 2022
• Study Completion (Anticipated): June 1, 2022

Study Registration Dates

• First Submitted: June 7, 2019
• First Submitted That Met QC Criteria: August 2, 2019
• First Posted (Actual): August 6, 2019

Study Record Updates

• Last Update Posted (Actual): December 29, 2021
• Last Update Submitted That Met QC Criteria: December 28, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: Ischemic stroke; Mechanical Thrombectomy
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: RECHMPL17_0378

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No