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Completed

NCT Number: NCT02971826

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospices Civils de Lyon - Neuroradiology unit

Bron, 69500, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

REVIVETM SE thrombectomy

Device

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Acronym: REVIVE SE

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Nov 23, 2016
Registry last updated
Dec 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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