Use of the Thrombectomy Device ReVive™ SE in the Acute Treatment of Stroke
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Hospices Civils de Lyon
- Enrollment
- 1
- Locations
- 1
- Primary Endpoint
- number of patients with a TICI score of 2b or 3 just after the thrombectomy
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- 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)
Arms & Interventions
Thrombectomy using the REVIVETM SE device
Thrombectomy using the REVIVETM SE device in patient with an ischemic stroke
Intervention: REVIVETM SE thrombectomy (Device)
Outcomes
Primary Outcomes
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
- Number of other procedures to treat the patient (thrombolysis, thromboaspiration, etc)(Day 0)
- Time to obtain the appropriate recanalization (TICI 2b or 3)(At the end of the procedure - Day 0)
- Number of the other devices use during the thrombectomy (Gidewire, catheter, etc.)(up to 2 days)