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

December 13, 2025 updated by: Hospices Civils de Lyon
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bron, France, 69500
        • Hospices Civils de Lyon - Neuroradiology unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
number of patients with a TICI score of 2b or 3 just after the thrombectomy
Time Frame: up to 2 days
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.)
Time Frame: up to 2 days
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)
Time Frame: Day 0
Review of the medical report which collected the acute treatments
Day 0
Time to obtain the appropriate recanalization (TICI 2b or 3)
Time Frame: At the end of the procedure - Day 0
Time of recanalization reported by the investigator on the medical report
At the end of the procedure - Day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Investigators

  • Principal Investigator: Françis TURJMAN, Hospices Civils de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 30, 2018

Primary Completion (Actual)

June 1, 2019

Study Completion (Actual)

June 1, 2019

Study Registration Dates

First Submitted

November 16, 2016

First Submitted That Met QC Criteria

November 21, 2016

First Posted (Estimated)

November 23, 2016

Study Record Updates

Last Update Posted (Estimated)

December 19, 2025

Last Update Submitted That Met QC Criteria

December 13, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 69HCL16_0571
  • 2016-A01470-51 (Other Identifier: ID-RCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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