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

Primary Purpose

Stroke

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
REVIVETM SE thrombectomy
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Stroke focused on measuring Stroke, thrombectomy, REVIVETM SE, MRI, Computed Tomography

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • Hospices Civils de Lyon - Neuroradiology unitRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Thrombectomy using the REVIVETM SE device

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Number of the other devices use during the thrombectomy (Gidewire, catheter, etc.)
Review of the medical report which collected the devices used
Number of other procedures to treat the patient (thrombolysis, thromboaspiration, etc)
Review of the medical report which collected the acute treatments
Time to obtain the appropriate recanalization (TICI 2b or 3)
Time of recanalization reported by the investigator on the medical report

Full Information

First Posted
November 16, 2016
Last Updated
January 29, 2019
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT02971826
Brief Title
Use of the Thrombectomy Device ReVive™ SE in the Acute Treatment of Stroke
Acronym
REVIVE SE
Official Title
Use of the Thrombectomy Device ReVive™ SE in the Acute Treatment of Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
November 30, 2018 (Actual)
Primary Completion Date
June 1, 2019 (Anticipated)
Study Completion Date
June 1, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Stroke, thrombectomy, REVIVETM SE, MRI, Computed Tomography

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Thrombectomy using the REVIVETM SE device
Arm Type
Experimental
Arm Description
Thrombectomy using the REVIVETM SE device in patient with an ischemic stroke
Intervention Type
Device
Intervention Name(s)
REVIVETM SE thrombectomy
Intervention Description
Mechanical thrombectomy using the REVIVETM SE device in patient with an ischemic stroke due to an intracranial arterial occlusion
Primary Outcome Measure Information:
Title
number of patients with a TICI score of 2b or 3 just after the thrombectomy
Description
The TICI score is a grading system which evaluate the degree of reperfusion as seen on arteriography
Time Frame
up to 2 days
Secondary Outcome Measure Information:
Title
Number of the other devices use during the thrombectomy (Gidewire, catheter, etc.)
Description
Review of the medical report which collected the devices used
Time Frame
up to 2 days
Title
Number of other procedures to treat the patient (thrombolysis, thromboaspiration, etc)
Description
Review of the medical report which collected the acute treatments
Time Frame
Day 0
Title
Time to obtain the appropriate recanalization (TICI 2b or 3)
Description
Time of recanalization reported by the investigator on the medical report
Time Frame
At the end of the procedure - Day 0

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Françis TURJMAN, MD
Phone
4 7235 74 05
Ext
+33
Email
francis.turjman@chu-lyon.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Claire Jossan
Phone
4 27 86 66 90
Ext
+33
Email
claire.jossan@chu-lyon.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Françis TURJMAN
Organizational Affiliation
Hospices Civils de Lyon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospices Civils de Lyon - Neuroradiology unit
City
Bron
ZIP/Postal Code
69500
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Françis TURJMAN, MD
Phone
4 7235 74 05
Ext
+33
Email
francis.turjman@chu-lyon.fr
First Name & Middle Initial & Last Name & Degree
Claire Jossan
Phone
4 27 86 66 90
Ext
+33
Email
claire.jossan@chu-lyon.fr
First Name & Middle Initial & Last Name & Degree
Françis TURJMAN, MD
First Name & Middle Initial & Last Name & Degree
Paul-Emile LABEYRIE, MD
First Name & Middle Initial & Last Name & Degree
Roberto RIVA, MD
First Name & Middle Initial & Last Name & Degree
Benjamin GORY, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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