This study is being conducted as a feasibility clinical investigation to collect safety and technical performance data of the WOLF Thrombectomy Device for the removal of thrombus in the neurovasculature.
This study has been designed as a prospective, non-randomized, multi-center, feasibility clinical investigation to evaluate the safety and device technical performance of the WOLF Thrombectomy Device in removing thrombus from an occluded large intracranial vessel(s) in patients with acute ischemic stroke. The device may be used alone or as an adjunct to intravenous tissue plasminogen activator (tPA) and/or to other traditional, thrombectomy modalities.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Mechanical thrombectomy for the neurovasculature
Hamilton General Hospital
Hamilton, Ontario, Canada
Royal University Hospital
Saskatoon, Saskatchewan, Canada
Primary Technical Success Endpoint
Technical Success defined as the ability to achieve a revascularization rate (Thrombolysis in cerebral infarction \[TICI\] 2b/3) of ≥50% with the first pass of the WOLF Thrombectomy device. Revascularization is assessed by the investigator using fluoroscopy and after the first pass of the device is assessed using the TICI scale. Additional passes will be performed as necessary and the total number of attempts to achieve revascularization documented.
Time frame: At index procedure
Primary Safety Endpoint
WOLF device-related adverse events (incidence, relationship to device and severity) at index procedure and through 24 hours post procedure.
Time frame: At index procedure and through 24 hours post procedure.
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