A Prospective, Multi-center and Randomized Controlled Clinical Trial to Assess the Safety and Effectiveness of Tianyi Revascularization Device of in the Revascularization of Large Vessel Occlusion in Acute Ischemic Stroke
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- AIS
- Sponsor
- Suzhou Zenith Vascular Scitech Co., Ltd.
- Enrollment
- 238
- Locations
- 1
- Primary Endpoint
- Revascularization assessed by digital subtraction angiography of the occluded target vessel to mTICI 2b or 3 at immediate post-procedure
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •aged 18-85 years
- •within 8 hours after symptom onset
- •The results showed that the scores of ASPECTS ≥6, 0\<NIHSS\<30 , and mRS \<2 ;
- •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;
- •Signed informed consent.
Exclusion Criteria
- •Clinical exclusion criteria:
- •Patients with epileptic seizure during stroke;
- •Patients with life expectancy less than 90 days;
- •Patients with intracranial hemorrhage or subarachnoid hemorrhage on the same side in recent 3 months;
- •Previous history of intracranial tumor, cerebral arteriovenous malformation or aneurysm without surgical treatment
- •Patients with a history of cerebral infarction or myocardial infarction or uncontrolled serious infectious diseases (such as endocarditis or septicemia) in recent 3 months;
- •Patients with gastrointestinal or urinary tract bleeding in the past three weeks;
- •Patients who have participated in clinical trials of other drugs or devices and have not been withdrawn from the group within the first one months of the screening period of this trial;
- •Patients with serious mental history, heart, liver, lung and kidney failure or other serious diseases;
- •Patients with active bleeding or known bleeding tendency (INR\>3.0 or platelet count\<40\*10\^9/L or APTT\>50 seconds);
Outcomes
Primary Outcomes
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
Secondary Outcomes
- 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)