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

NCT02971826 | Completed

• 2 other identifiers: 69HCL16_05712016-A01470-51
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

Stroke; thrombectomy; REVIVETM SE; MRI; Computed Tomography

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Number of the other devices use during the thrombectomy (Gidewire, catheter, etc.)

  up to 2 days

• Number of other procedures to treat the patient (thrombolysis, thromboaspiration, etc)

  Day 0

• Time to obtain the appropriate recanalization (TICI 2b or 3)

  At the end of the procedure - Day 0

Study Arms (1)

Thrombectomy using the REVIVETM SE device

EXPERIMENTAL

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

Device: REVIVETM SE thrombectomy

Interventions

REVIVETM SE thrombectomy DEVICE

Mechanical thrombectomy using the REVIVETM SE device in patient with an ischemic stroke due to an intracranial arterial occlusion

Thrombectomy using the REVIVETM SE device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hospices Civils de Lyon - Neuroradiology unit

Bron, 69500, France

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Françis TURJMAN

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2016
• First Posted: November 23, 2016
• Study Start: November 30, 2018
• Primary Completion: June 1, 2019
• Study Completion: June 1, 2019
• Last Updated: December 19, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)