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

NCT03820882 | Completed DMC

• 1 other identifier: JSSKBMCT001
• Study Type: interventional
• Target: 238
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Time to achieve recanalization

  intraprocedure immediate

• NIHSS score at 24±2 hours

  24±2 hours

• NIHSS score at 7±1 days or discharge

  7±1 days

• proportion of patients who got a mRS 0-2 at 90±14 days

  90±14 days

• symptomatic intracranial hemorrhage after procedure

  24±2 hours

Study Arms (2)

stent retriever(Catfish)

EXPERIMENTAL

Mechanical thrombectomy with Catfish flow restoration device

Device: Catfish

stent retriever(Solitaire FR)

ACTIVE COMPARATOR

Mechanical thrombectomy with Solitaire FR flow restoration device

Device: Solitaire FR

Interventions

Catfish DEVICE

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

stent retriever(Catfish)

Solitaire FR DEVICE

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

stent retriever(Solitaire FR)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≤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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Beijing Tiantan hospital, Capital Medical University

Beijing, Beijing Municipality, 10000, China

Location

Related Publications (1)

• Luo G, Yan X, Xiao G, Wei L, Nai Bi Jiang YLK, Ma R, Chen W, Fang C, Zhou Z, Wan J, Peng Y, Zhang G, Zhao J, Li L, Yuan H, Wu J, Li B, Zhang F, Cheng Y, Gao F, Miao Z. Comparing a novel Catfish flow restoration device and the Solitaire stent retriever for thrombectomy revascularisation in emergent largevessel occlusion stroke: a prospective randomised controlled study. Stroke Vasc Neurol. 2023 Dec 29;8(6):435-443. doi: 10.1136/svn-2022-002036.

  PMID: 37045544 DERIVED

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Zhongrong Miao, MD

  Beijing Tiantan Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Head of Neurointerventional, Principal Investigator, Clinical Professor

Model Details: prospective, randomized, open-label, parallel assignment

Study Record Dates

• First Submitted: January 14, 2019
• First Posted: January 29, 2019
• Study Start: March 3, 2019
• Primary Completion: January 5, 2021
• Study Completion: June 5, 2021
• Last Updated: September 27, 2022

Record last verified: 2022-09

Locations

CN (1)