This is a prospective, randomized, single blind, concurrent controlled, multi-center study. Patients presenting with symptoms of acute ischemic stroke who have evidence of a large vessel occlusion in the cerebral circulation.
This is a prospective, randomized, single blind, concurrent controlled, multi-center study. Patients presenting with symptoms of acute ischemic stroke who have evidence of a large vessel occlusion in the cerebral circulation will be assigned to either the Tianyi Revascularization Device or Solitaire FR Revascularization Device. Each treated patient will be followed and assessed for 3 months after randomization. Up to 238 evaluable patients at up to 18 centers presenting with acute ischemic stroke in vessels accessible to the Revascularization Device for revascularization within 8 hours of symptom onset. The hypothesis to be tested is that the safety and effectiveness of the Tianyi Revascularization Device for the revascularization of large vessel occlusion is not inferior to the Solitaire FR Revascularization Device.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
238
Revascularization Device using the Mechanical thrombectomy technique for recanalization of an occlusion large vessel in the brain
Revascularization Device using the Mechanical thrombectomy technique for recanalization of an occlusion large vessel in the brain
Shanghai Changhai Hospital
Shanghai, China
Revascularization assessed by digital subtraction angiography of the occluded target vessel to mTICI 2b or 3 at immediate post-procedure
Time frame: At immediate post-procedure
Times to revascularization(From groin puncture to final revascularization result)
Time frame: At immediate post-procedure
NIHSS score at 24h, 7-day or discharge
Time frame: Within 24 hours,7-day or discharge post-procedure, whichever came first
Functional patient outcome at 90 days post-procedure as defined by a modified Rankin Score (mRS) 0-2
Time frame: at 90 days post-procedure
Device Technical Success
Time frame: At immediate post-procedure
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