Catfish Flow Restoration Device for Thrombectomy Revascularisation of Large Vessel Occlusions in Acute Ischemic Stroke: a Randomised, Parallel-group, Non-inferiority Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Acute Ischemic Stroke
- Sponsor
- Ministry of Science and Technology of the People´s Republic of China
- Enrollment
- 238
- Locations
- 1
- Primary Endpoint
- Instant recanalization rate (mTICI 2b-3) of target vessel after the procedure
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
The study is a randomized, prospective, parallel-group, multicenter, open-label, non-inferiority trial. Patients are randomized 1 : 1 to either stent retriever(Catfish) or Solitaire for endovascular therapy for acute ischemic stroke. The study aims to evaluate the benefit and safety of stent retriever(Catfish) for acute ischemic stroke therapy, as compared to Solitaire FR.
Detailed Description
The main objective is to determine whether stent retriever(Catfish) will have non-inferior successful recanalization rate compared to Solitaire in patients with acute ischemic stroke caused by large vessel occlusion. The secondary objectives is to verify whether there is significant differences in time from artery puncture to successful recanalization (mTICI 2b or greater), NIHSS score at 24 hours and at 7 days or discharge if earlier, good clinical outcomes at 90 days (defined as mRS score ≤2) between stent retriever(Catfish) and Solitaire in patients with acute ischemic stroke caused by large vessel occlusion. The third objectives is to compare the rate of symptomatic intracranial hemorrhage, serious adverse event(SAE), all cause of mortality with 90 days after operation, between stent retriever (Catfish) and Solitaire in patients with acute ischemic stroke due to large vessel occlusion.
Investigators
Zhongrong Miao
Director, Head of Neurointerventional, Principal Investigator, Clinical Professor
Ministry of Science and Technology of the People´s Republic of China
Eligibility Criteria
Inclusion Criteria
- •18≤ages≤80;
- •mRS score must lower than 2 Pre-AIS(acute ischemic stroke).
- •Baseline NIHSS score obtained prior to randomization must be between 8 and 25;
- •Symptoms and signs in accordance with Large vessel occlusion, confirmed by CTA(CT angiogram)/MRA(magnetic resonance angiography )/DSA;
- •Patient treatable within 8 hours of symptom onset (symptoms onset is defined as point in time the patient was last seen well (at baseline)) can accept the complete femoral artery puncture;
- •Baseline Alberta stroke program early CT score (ASPECTS) or posterior circulation Alberta stroke program early CT score (pc-ASPECTS)≥ 6 on Computed tomography (CT) or magnetic resonance imaging(MRI).
- •The patient or relative give written informed consent.
Exclusion Criteria
- •History of stroke in past 3 months.
- •Presumed septic embolus, or suspicion of bacterial endocarditis.
- •Evidence of tortuosity of cervical vessels precluding device delivery/deployment;
- •Hypertension (Systolic blood pressure(SBP)\>185 mmHg or diastolic blood pressure(DBP)\>110 mm Hg) after using drug;
- •Platelet count\<30,000/μL and use of Novel Anticoagulant with International Normalized Ratio(INR)\>3.0;
- •Random blood glucose of\<2.7mmol/L or\>22.2mmol/L;
- •Patients with heart or lung or liver or renal failure or other sever disease (intracranial tumors, cerebral arteriovenous malformation (AVM), systemic infection, active disseminated intravascular coagulation, history of sever psychosis);
- •Patients with Dementia or psychiatric disease that would confound the neurological or functional evaluations.
- •Anticipated life expectancy of less than 6 months;
- •Known serious sensitivity to contrast medium and nitinol metal;
Outcomes
Primary Outcomes
Instant recanalization rate (mTICI 2b-3) of target vessel after the procedure
Time Frame: immediate
Successful recanalization is defined as modified Thrombolysis In Cerebral Ischemia scale 2b or 3. And it is evaluated by DSA(digital subtraction angiography ) intraoperative immediately in both treatment groups
Secondary Outcomes
- Time to achieve recanalization(intraprocedure immediate)
- all cause of mortality within 90±14 days after procedure(90±14 days)
- NIHSS score at 7±1 days or discharge(7±1 days)
- NIHSS score at 24±2 hours(24±2 hours)
- proportion of patients who got a mRS 0-2 at 90±14 days(90±14 days)
- serious adverse event(SAE) within 90±14 days after procedure(90±14 days)
- symptomatic intracranial hemorrhage after procedure(24±2 hours)