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

Civil Hospices of Lyon

Status: Completed

Conditions: Stroke

Treatments: Device: REVIVETM SE thrombectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT02971826

2016-A01470-51 (Other Identifier)

69HCL16_0571

Details and patient eligibility

About

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.

Enrollment: 1 patient

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1 participants in 1 patient group

Thrombectomy using the REVIVETM SE device

Experimental group

Description:

Thrombectomy using the REVIVETM SE device in patient with an ischemic stroke

Treatment:

Device: REVIVETM SE thrombectomy