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

• Sponsor: Hospices Civils de Lyon (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02971826
• Collaborator: (none)
• Enrollment: 15
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 6
• Patients Per Site Per Month: 2.5

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke	Device: REVIVETM SE thrombectomy	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 15 participants
• Allocation: N/A
• 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
• Actual Study Start Date: Nov 30, 2018
• Anticipated Primary Completion Date: Jun 1, 2019
• Anticipated Study Completion Date: Jun 1, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. number of patients with a TICI score of 2b or 3 just after the thrombectomy [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.) [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) [Day 0]

   Review of the medical report which collected the acute treatments

3. Time to obtain the appropriate recanalization (TICI 2b or 3) [At the end of the procedure - Day 0]

   Time of recanalization reported by the investigator on the medical report

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospices Civils de Lyon - Neuroradiology unit	Bron		France	69500

Sponsors and Collaborators

• Hospices Civils de Lyon

Investigators

• Principal Investigator: Françis TURJMAN, Hospices Civils de Lyon

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hospices Civils de Lyon
• ClinicalTrials.gov Identifier: NCT02971826
• Other Study ID Numbers: 69HCL16_0571; 2016-A01470-51
• First Posted: Nov 23, 2016
• Last Update Posted: Jan 30, 2019
• Last Verified: Jan 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• 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

Study Results

No Results Posted as of Jan 30, 2019