Status
Conditions
About
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).
Enrollment
Sex
Ages
Volunteers
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.
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal