Acute Ischemic Stroke, AIS, Large Vessel Occlusion, Thrombectomy
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICETianyi Revascularization Device
Revascularization Device using the Mechanical thrombectomy technique for recanalization of an occlusion large vessel in the brain
DEVICESolitaire FR Revascularization Device
Revascularization Device using the Mechanical thrombectomy technique for recanalization of an occlusion large vessel in the brain
Sponsors
Suzhou Zenith Vascular Scitech Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. aged 18-85 years 2. within 8 hours after symptom onset 3. The results showed that the scores of ASPECTS ≥6, 0\<NIHSS\<30 , and mRS \<2 ; 4. caused by a large vessel occlusion of the anterior circulation (internal carotid artery or the M1 and M2 segments of MCA and the A1 and A2 segments) cerebral artery confirmed by DSA; 5. Signed informed consent.
Exclusion criteria
Clinical
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Revascularization assessed by digital subtraction angiography of the occluded target vessel to mTICI 2b or 3 at immediate post-procedure | At immediate post-procedure |
Secondary
| Measure | Time frame |
|---|---|
| Times to revascularization（From groin puncture to final revascularization result） | At immediate post-procedure |
| NIHSS score at 24h, 7-day or discharge | 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 | at 90 days post-procedure |
| Device Technical Success | At immediate post-procedure |
Other
| Measure | Time frame |
|---|---|
| All causes of mortality at 90 days | at 90 days post-procedure |
| Occurrence of serious adverse events or adverse events related to device or procedure | at 90 days post-procedure |
| Occurrence of device defect | at 90 days post-procedure |
| Occurrence of symptomatic intracranial hemorrhages (sICH) at 24 hours | Within 24 hours post-procedure |
Countries
China
Outcome results
None listed