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

Stroke Clinical Trial

— REVIVE SE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02971826
• Other study ID #: 69HCL16_0571
• Secondary ID: 2016-A01470-51
• Status: Recruiting
• Phase: N/A
• Start date: November 30, 2018
• Est. completion date: June 1, 2019

Study information

• Verified date: January 2019
• Source: Hospices Civils de Lyon
• Contact: Françis TURJMAN, MD
• Phone: 4 7235 74 05
• Email: francis.turjman[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: June 1, 2019
• Est. primary completion date: June 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Stroke

Intervention

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

Locations

Country	Name	City	State
France	Hospices Civils de Lyon - Neuroradiology unit	Bron

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of the other devices use during the thrombectomy (Gidewire, catheter, etc.)	Review of the medical report which collected the devices used	up to 2 days
Secondary	Number of other procedures to treat the patient (thrombolysis, thromboaspiration, etc)	Review of the medical report which collected the acute treatments	Day 0
Secondary	Time to obtain the appropriate recanalization (TICI 2b or 3)	Time of recanalization reported by the investigator on the medical report	At the end of the procedure - Day 0