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

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ClinicalTrials.gov Identifier: NCT02971826
Recruitment Status : Not yet recruiting
First Posted : November 23, 2016
Last Update Posted : July 26, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Stroke Device: REVIVETM SE thrombectomy Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Use of the Thrombectomy Device ReVive™ SE in the Acute Treatment of Stroke
Estimated Study Start Date : October 1, 2018
Estimated Primary Completion Date : May 1, 2019
Estimated Study Completion Date : May 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caffeine

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




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02971826


Contacts
Contact: Françis TURJMAN, MD 4 7235 74 05 ext +33 francis.turjman@chu-lyon.fr
Contact: Claire Jossan 4 27 86 66 90 ext +33 claire.jossan@chu-lyon.fr

Locations
France
Hospices Civils de Lyon - Neuroradiology unit Not yet recruiting
Bron, France, 69500
Contact: Françis TURJMAN, MD    4 7235 74 05 ext +33    francis.turjman@chu-lyon.fr   
Contact: Claire Jossan    4 27 86 66 90 ext +33    claire.jossan@chu-lyon.fr   
Principal Investigator: Françis TURJMAN, MD         
Sub-Investigator: Paul-Emile LABEYRIE, MD         
Sub-Investigator: Roberto RIVA, MD         
Sub-Investigator: Benjamin GORY, MD         
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
Principal Investigator: Françis TURJMAN Hospices Civils de Lyon

Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT02971826     History of Changes
Other Study ID Numbers: 69HCL16_0571
2016-A01470-51 ( Other Identifier: ID-RCB )
First Posted: November 23, 2016    Key Record Dates
Last Update Posted: July 26, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hospices Civils de Lyon:
Stroke
thrombectomy
REVIVETM SE
MRI
Computed Tomography

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases