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The main objective of this study is to assess the safety and effectiveness of the ReVive SE (Self- Expanding) Neurothrombectomy Device in subjects requiring mechanical thrombectomy when used according to its Instruction for use (IFU).
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| Measure | Description | Time Frame |
|---|---|---|
| modified Rankin Scale | Functional Independence of subjects as defined by modified Rankin Scale (mRS) ≤2 at 90 days post-procedure. | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| National Institute of Health Stroke Scale (NIHSS) | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| emboli occurence | 90 | |
| symptomatic intracranial hemorrhage (sICH) | 90 days | |
| Mortality |
Inclusion Criteria:
Exclusion Criteria:
Life expectancy of less than 90 days
Neurological signs that are rapidly improving prior to or at time of treatment (NIHSS improves at least 4 points between subject presentation and treatment initiation)
Subject is either exhibiting clinical signs suggestive of, or there is angiographic evidence of bilateral stroke
Prior use of any other mechanical device to treat this stroke (e.g., Merci Retriever, Penumbra, Solitaire, Trevo, Mindframe, Phenox, stent)
Known bleeding diathesis:
Glucose <50 mg/dL (2.8 mmol, 2.6mM)
Uncontrolled hypertension (SBP>185 or DBP>110) refractory to pharmacological management
Known hypersensitivity or allergy to nitinol and/or radiographic contrast agents
Pregnancy or lactating female
Subject already enrolled in a clinical study involving experimental medication or device
Imaging Exclusion criteria:
CT scan or MRI with evidence of acute intracranial hemorrhage, mass effect and/or intracranial tumor.
Angiographic evidence of carotid dissection, or high grade stenosis (> 50% stenosis of the artery proximal to the target vessel) that will prevent access to the clot, or cerebral vasculitis
Blood vessel with extreme tortuosity or other conditions preventing the access of the device.
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subjects requiring mechanical thrombectomy
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| Name | Affiliation | Role |
|---|---|---|
| Benjamin Hoehn, MD | Codman Neuro | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Bordeaux | Bordeaux | France | ||||
| CHU Clermont Ferrand |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| 90 days |
| Clermont-Ferrand |
| France |
| CHU de Colmar | Colmar | France |
| CHU Dijon | Dijon | France |
| CHU Lille | Lille | France |
| CHU La Timone | Marseille | France |
| CHU St Etienne | Saint-Etienne | France |
| Hôpital Bretonneau | Tours | France |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |