Status:
COMPLETED
Stent Retriever for Thrombectomy Revascularisation of Large Vessel Occlusions in Acute Ischemic Stroke(Catfish)
Lead Sponsor:
Ministry of Science and Technology of the People´s Republic of China
Conditions:
Acute Ischemic Stroke
Eligibility:
All Genders
18-80 years
Phase:
NA
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 t...
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 v...
Eligibility Criteria
Inclusion
- 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
- 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;
- Females who are pregnant or breastfeeding;
- Current participation in any other clinical trial;
- The patient or the patient's legally authorized representative hasn't signed and dated an informed consent form;
- Rapidly improving neurologic examination.
- Excessive vascular access tortuosity that will likely result in unstable access platform.
- Seizures at stroke onset which would preclude obtaining a baseline NIHSS.
- Suspected intracranial dissection or cerebral vasculitis.
- Evidence of tandem cervical occlusion, or stenosis requiring treatment.
- Major surgery or significant trauma in the past 30 days or plan to have surgery in next 3 months after enrolled.
- CT or MRI evidence of mass effect or intra-cranial tumour (except small meningioma)
- Any type of cerebral hemorrhage (only microbleeds are allowed) on neuroimaging
- The subject is not appropriate for mechanical thrombectomy intervention in the opinion of the investigator.
Key Trial Info
Start Date :
March 3 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 5 2021
Estimated Enrollment :
238 Patients enrolled
Trial Details
Trial ID
NCT03820882
Start Date
March 3 2019
End Date
June 5 2021
Last Update
September 27 2022
Active Locations (1)
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1
Beijing Tiantan hospital, Capital Medical University
Beijing, Beijing Municipality, China, 10000