Informations générales (source: ClinicalTrials.gov)
Use of the Thrombectomy Device ReVive™ SE in the Acute Treatment of Stroke (REVIVE SE)
Interventional
N/A
Hospices Civils de Lyon (Voir sur ClinicalTrials)
novembre 2018
juin 2019
29 juin 2024
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.
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| Hospices Civils de Lyon - Neuroradiology unit - 69500 - Bron - France | Françis TURJMAN, MD | Contact (sur clinicalTrials) | |||
Critères
Tous
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
- 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
- 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)