Stent Retriever for Thrombectomy Revascularisation of Large Vessel Occlusions in Acute Ischemic Stroke(Catfish)

Catfish Flow Restoration Device for Thrombectomy Revascularisation of Large Vessel Occlusions in Acute Ischemic Stroke: a Randomised, Parallel-group, Non-inferiority Trial

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.

Study Overview

• Status: Completed
• Conditions: Acute Ischemic Stroke
• Intervention / Treatment: Device: Catfish; Device: 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.

• Study Type: Interventional
• Enrollment (Actual): 238
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 10000
      • Beijing Tiantan Hospital, Capital Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: stent retriever(Catfish); Mechanical thrombectomy with Catfish flow restoration device	Device: Catfish; Patients will be treated for mechanical recanalization with Catfish within 8 hours after stroke onset plus standard medical management.
Active Comparator: stent retriever(Solitaire FR); Mechanical thrombectomy with Solitaire FR flow restoration device	Device: Solitaire FR; Patients will be treated for mechanical recanalization with Solitaire FR within 8 hours after stroke onset plus standard medical management.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Instant recanalization rate (mTICI 2b-3) of target vessel after the procedure	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	immediate

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to achieve recanalization	The period from femoral artery puncture to successful recanalization	intraprocedure immediate
NIHSS score at 24±2 hours	National Institutes of Health Stroke Scale( NIHSS),the NIHSS is a stroke severity score that is composed of 11 items; range from 0 to 42, higher values indicate more severe deficits	24±2 hours
NIHSS score at 7±1 days or discharge	National Institutes of Health Stroke Scale( NIHSS),the NIHSS is a stroke severity score that is composed of 11 items; range from 0 to 42, higher values indicate more severe deficits	7±1 days
proportion of patients who got a mRS 0-2 at 90±14 days	The proportion of patients who got a mRS 0-2 in patients who receive stent retriever treatment.the mRs is an ordinal disability score of 7 categories (0 = no symptoms to 5 = severe disability, and 6 = death)	90±14 days
symptomatic intracranial hemorrhage after procedure	sICH was defined as any type of ICH on neuroimaging after the treatment within 24±2 hours after procedure with increasing of ≥4 points on NIHSS, National Institutes of Health Stroke Scale( NIHSS),the NIHSS is a stroke severity score that is composed of 11 items; range from 0 to 42, higher values indicate more severe deficits	24±2 hours
serious adverse event(SAE) within 90±14 days after procedure		90±14 days
all cause of mortality within 90±14 days after procedure		90±14 days

Collaborators and Investigators

• Sponsor: Ministry of Science and Technology of the People´s Republic of China

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2019
• Primary Completion (Actual): January 5, 2021
• Study Completion (Actual): June 5, 2021

Study Registration Dates

• First Submitted: January 14, 2019
• First Submitted That Met QC Criteria: January 27, 2019
• First Posted (Actual): January 29, 2019

Study Record Updates

• Last Update Posted (Actual): September 27, 2022
• Last Update Submitted That Met QC Criteria: September 23, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Ischemia; Infarction; Brain Infarction; Stroke; Ischemic Stroke; Ischemia; Cerebral Infarction
• Other Study ID Numbers: JSSKBMCT001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No