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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03820882
Recruitment Status : Unknown
Verified January 2019 by Zhongrong Miao, Capital Medical University.
Recruitment status was:  Not yet recruiting
First Posted : January 29, 2019
Last Update Posted : January 29, 2019
Sponsor:
Information provided by (Responsible Party):
Zhongrong Miao, Capital Medical University

Brief Summary:
The study is a prospective, multi-center, stratified randomized, single-blind, parallel assignment, active control, 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.

Condition or disease Intervention/treatment Phase
Acute Ischemic Stroke Device: Catfish Device: Solitaire FR Not Applicable

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 to achieve recanalization, NIHSS score, mRS(modified Rankin Scale) score 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 238 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: prospective, randomized, open-label, parallel assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Catfish Flow Restoration Device for Thrombectomy Revascularisation of Large Vessel Occlusions in Acute Ischemic Stroke: a Randomised, Parallel-group, Non-inferiority Trial
Estimated Study Start Date : February 10, 2019
Estimated Primary Completion Date : February 10, 2020
Estimated Study Completion Date : April 10, 2020

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.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Time to achieve recanalization [ Time Frame: intraprocedure immediate ]
    The period from femoral artery puncture to successful recanalization

  2. NIHSS score at randomization [ Time Frame: randomization ]
    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

  3. NIHSS score at 24±2 hours [ Time Frame: 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

  4. NIHSS score at 7±1 days or discharge [ Time Frame: 7±1 days ]
    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

  5. proportion of patients who got a mRS 0-2 at 90±14 days [ Time Frame: 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)

  6. symptomatic intracranial hemorrhage after procedure [ Time Frame: 24±2 hours ]
    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

  7. serious adverse event(SAE) within 90±14 days after procedure [ Time Frame: 90±14 days ]
  8. all cause of mortality within 90±14 days after procedure [ Time Frame: 90±14 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 anterior circulation ischemia and large vessel occlusion (ICA, MCA(middle cerebral arterial)-M1 or M2, ACA(arteriae cerebral anterior) A1 or A2, 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) (anterior circulation) ≥ 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03820882


Contacts
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Contact: Zhongrong Miao, MD 86-010-67098857 13601243293@163.com
Contact: Jian Sun, Master 86-15201580407 690035988@qq.com

Sponsors and Collaborators
Ministry of Science and Technology of the People´s Republic of China
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Responsible Party: Zhongrong Miao, Director, Head of Neurointerventional, Principal Investigator, Clinical Professor, Capital Medical University
ClinicalTrials.gov Identifier: NCT03820882    
Other Study ID Numbers: JSSKBMCT001
First Posted: January 29, 2019    Key Record Dates
Last Update Posted: January 29, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stroke
Cerebral Infarction
Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Infarction
Brain Ischemia