Clinical trial NCT03820882: Stent Retriever for Thrombectomy Revascularisation of Large Vessel Occlusions in Acute Ischemic Stroke(Catfish)
Official title: Catfish Flow Restoration Device for Thrombectomy Revascularisation of Large Vessel Occlusions in Acute Ischemic Stroke: a Randomised, Parallel-group, Non-inferiority Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Ischemic Stroke
Lead sponsor: Ministry of Science and Technology of the People´s Republic of China
Sponsor class: OTHER_GOV
First posted: 2019-01-29
Enrollment: 238
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective, randomized, open-label, parallel assignment
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. 18≤ages≤80;
2. mRS score must lower than 2 Pre-AIS(acute ischemic stroke).
3. Baseline NIHSS score obtained prior to randomization must be between 8 and 25;
4. Symptoms and signs in accordance with Large vessel occlusion, confirmed by CTA(CT angiogram)/MRA(magnetic resonance angiography )/DSA;
5. 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;
6. 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).
7. The patient or relative give written informed consent.

Exclusion Criteria:

1. History of stroke in past 3 months.
2. Presumed septic embolus, or suspicion of bacterial endocarditis.
3. Evidence of tortuosity of cervical vessels precluding device delivery/deployment;
4. Hypertension (Systolic blood pressure(SBP)\>185 mmHg or diastolic blood pressure(DBP)\>110 mm Hg) after using drug;
5. Platelet count\<30,000/μL and use of Novel Anticoagulant with International Normalized Ratio(INR)\>3.0;
6. Random blood glucose of\<2.7mmol/L or\>22.2mmol/L;
7. 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);
8. Patients with Dementia or psychiatric disease that would confound the neurological or functional evaluations.
9. Anticipated life expectancy of less than 6 months;
10. Known serious sensitivity to contrast medium and nitinol metal;
11. Females who are pregnant or breastfeeding;
12. Current participation in any other clinical trial;
13. The patient or the patient's legally authorized representative hasn't signed and dated an informed consent form;
14. Rapidly improving neurologic examination.
15. Excessive vascular access tortuosity that will likely result in unstable access platform.
16. Seizures at stroke onset which would preclude obtaining a baseline NIHSS.
17. Suspected intracranial dissection or cerebral vasculitis.
18. Evidence of tandem cervical occlusion, or stenosis requiring treatment.
19. Major surgery or significant trauma in the past 30 days or plan to have surgery in next 3 months after enrolled.
20. CT or MRI evidence of mass effect or intra-cranial tumour (except small meningioma)
21. Any type of cerebral hemorrhage (only microbleeds are allowed) on neuroimaging
22. The subject is not appropriate for mechanical thrombectomy intervention in the opinion of the investigator.

Primary outcomes:
measure: Instant recanalization rate (mTICI 2b-3) of target vessel after the procedure
timeFrame: immediate
Secondary outcomes:
measure: Time to achieve recanalization
timeFrame: intraprocedure immediate
measure: NIHSS score at 24±2 hours
timeFrame: 24±2 hours
measure: NIHSS score at 7±1 days or discharge
timeFrame: 7±1 days
measure: proportion of patients who got a mRS 0-2 at 90±14 days
timeFrame: 90±14 days
measure: symptomatic intracranial hemorrhage after procedure
timeFrame: 24±2 hours
measure: serious adverse event(SAE) within 90±14 days after procedure
timeFrame: 90±14 days
measure: all cause of mortality within 90±14 days after procedure
timeFrame: 90±14 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan hospital, Capital Medical University
state: Beijing
Study officials:
affiliation: Beijing Tiantan Hospital
name: Zhongrong Miao, MD
role: PRINCIPAL_INVESTIGATOR
References: