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

• ClinicalTrials.gov Identifier: NCT03820882
• Recruitment Status: Unknown
• First Posted: January 29, 2019
• Last Update Posted: January 29, 2019
• Sponsor: Ministry of Science and Technology of the People´s Republic of China
• Information provided by (Responsible Party): Zhongrong Miao, Capital Medical University

Tracking Information

• First Submitted Date: January 14, 2019
• First Posted Date: January 29, 2019
• Last Update Posted Date: January 29, 2019
• Estimated Study Start Date: February 10, 2019
• Estimated Primary Completion Date: February 10, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 27, 2019)

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

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: January 27, 2019)

• Time to achieve recanalization [ Time Frame: intraprocedure immediate ]
  The period from femoral artery puncture to successful recanalization
• 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
• 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
• 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
• 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)
• 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
• serious adverse event(SAE) within 90±14 days after procedure [ Time Frame: 90±14 days ]
• all cause of mortality within 90±14 days after procedure [ Time Frame: 90±14 days ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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.

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.

• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

prospective, randomized, open-label, parallel assignment

Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment

• Condition: Acute Ischemic Stroke

Intervention

• Device: Catfish
  Patients will be treated for mechanical recanalization with Catfish within 8 hours after stroke onset plus standard medical management.
• Device: Solitaire FR
  Patients will be treated for mechanical recanalization with Solitaire FR within 8 hours after stroke onset plus standard medical management.

Study Arms

• Experimental: stent retriever(Catfish)
  Mechanical thrombectomy with Catfish flow restoration device
  Intervention: Device: Catfish
• Active Comparator: stent retriever(Solitaire FR)
  Mechanical thrombectomy with Solitaire FR flow restoration device
  Intervention: Device: Solitaire FR

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: January 27, 2019): 238
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: April 10, 2020
• Estimated Primary Completion Date: February 10, 2020 (Final data collection date for primary outcome measure)

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 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT03820882
• Other Study ID Numbers: JSSKBMCT001
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Responsible Party: Zhongrong Miao, Capital Medical University
• Study Sponsor: Ministry of Science and Technology of the People´s Republic of China
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Ministry of Science and Technology of the People´s Republic of China
• Verification Date: January 2019