Use of the Thrombectomy Device ReVive™ SE in the Acute Treatment of Stroke

Study Overview
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Brief Summary
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The last marketed thrombectomy devices, named stentretriever, permit a better and faster recanalization in patient with a stroke. The REVIVETM SE is a device designed to restore the brain perfusion in patient with an intracranial artery occlusion. The REVIVETM Se device is not widely use in Europe and in France. The objective of this study is to assess the interest of using this device in the standard care of ischemic stroke in the radiology unit of the hospital Pierre Wertheimer, Lyon. The medical care will not be modified but data will be collected in order to determine whether or not this device is useful for the practice of the radiology unit.

Official Title
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Use of the Thrombectomy Device ReVive™ SE in the Acute Treatment of Stroke

Conditions
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Stroke

Intervention / Treatment
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* Device: REVIVETM SE thrombectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient with an ischemic stroke detected by Computed Tomography (CT) or Magnetic Resonance Image (MRI) Large proximal arterial occlusion : M1 segment of the Middle cerebral artery (MCA), Internal Carotid Artery (ICA) or Basilar Artery (BA) Last known well (without neurological symptoms) ≤ 8 hours of treatment initiation Score NIHSS ≥4 Eligibility on an endovascular procedure using REVIVETM SE device No opposition of the patient to participate at the study Exclusion Criteria: Diagnostic cerebral imaging impossible Distal occlusion Tortuous vessel or other specificity preventing the access of device Vessel diameter < 1.5 mm Known hypersensibility or allergy to nitinol Subjects not covered by or having the right to social security Deprivation of civil rights (guardianship, safeguard justice)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Thrombectomy using the REVIVETM SE device<br>Thrombectomy using the REVIVETM SE device in patient with an ischemic stroke | Device: REVIVETM SE thrombectomy<br>* Mechanical thrombectomy using the REVIVETM SE device in patient with an ischemic stroke due to an intracranial arterial occlusion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of patients with a TICI score of 2b or 3 just after the thrombectomy | The TICI score is a grading system which evaluate the degree of reperfusion as seen on arteriography | up to 2 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of the other devices use during the thrombectomy (Gidewire, catheter, etc.) | Review of the medical report which collected the devices used | up to 2 days | 
| Number of other procedures to treat the patient (thrombolysis, thromboaspiration, etc) | Review of the medical report which collected the acute treatments | Day 0 | 
| Time to obtain the appropriate recanalization (TICI 2b or 3) | Time of recanalization reported by the investigator on the medical report | At the end of the procedure - Day 0 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke, thrombectomy, REVIVETM SE, MRI, Computed Tomography