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

Not Applicable

• Conditions: Stroke
• Interventions: Device: REVIVETM SE thrombectomy

• Registration Number: NCT02971826
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-11-16
• Study First Submitted QC: 2016-11-21
• Study First Posted: 2016-11-23
• Study Start: 2018-11-30
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-29
• Last Update Posted: 2019-01-30
• Primary Completion: 2019-06-01
• Study Completion: 2019-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Thrombectomy using the REVIVETM SE device	REVIVETM SE thrombectomy	Thrombectomy using the REVIVETM SE device in patient with an ischemic stroke

Primary Outcome Measures

Name	Time	Method
number of patients with a TICI score of 2b or 3 just after the thrombectomy	up to 2 days	The TICI score is a grading system which evaluate the degree of reperfusion as seen on arteriography

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hospices Civils de Lyon - Neuroradiology unit; 🇫🇷 Bron, France