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Acute Ischemic StrokeNCT03820882

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

A study testing Catfish and Solitaire FR in people with Acute Ischemic Stroke, run by Ministry of Science and Technology of the People´s Republic of China at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Acute Ischemic Stroke
What is being tested?
Catfish and Solitaire FR
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
238 participants
Where
1 siteChina
Study dates
3 Mar 2019to 5 Jun 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18≤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.

Who cannot join

  • 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;
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  • 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.
  • Seizures at stroke onset which would preclude obtaining a baseline NIHSS.
  • Suspected intracranial dissection or cerebral vasculitis.
  • Evidence of tandem cervical occlusion, or stenosis requiring treatment.
  • Major surgery or significant trauma in the past 30 days or plan to have surgery in next 3 months after enrolled.
  • CT or MRI evidence of mass effect or intra-cranial tumour (except small meningioma)
  • Any type of cerebral hemorrhage (only microbleeds are allowed) on neuroimaging
  • The subject is not appropriate for mechanical thrombectomy intervention in the opinion of the investigator.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Beijing Tiantan hospital, Capital Medical University

    Beijing, Beijing Municipality, 10000

Other trials in China

About this study

Official title: 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.

Read the 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.

Being tested
Catfish, Solitaire FR
Medical subject headings
Ischemic Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CatfishDevice

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

  • Solitaire FRDevice

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

Study groups in NCT03820882
Study groupRoleWhat they receive
stent retriever(Catfish)ExperimentalMechanical thrombectomy with Catfish flow restoration device
Receives: Device: Catfish
stent retriever(Solitaire FR)Active comparatorMechanical thrombectomy with Solitaire FR flow restoration device
Receives: Device: Solitaire FR

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: immediate

Secondary outcomes (7)

  1. Time to achieve recanalization

    The period from femoral artery puncture to successful recanalization

    Measured: intraprocedure immediate

  2. 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

    Measured: 24±2 hours

  3. 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

    Measured: 7±1 days

  4. 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)

    Measured: 90±14 days

  5. 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

    Measured: 24±2 hours

  6. serious adverse event(SAE) within 90±14 days after procedure

    Measured: 90±14 days

  7. all cause of mortality within 90±14 days after procedure

    Measured: 90±14 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jan 2019
  2. Study start3 Mar 2019
  3. Primary completion5 Jan 2021
  4. Study completion5 Jun 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
prospective, randomized, open-label, parallel assignment
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
238 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03820882
Sponsor's protocol ID
JSSKBMCT001
Status last verified
Sep 2022
First submitted
14 Jan 2019
Last updated
27 Sep 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 37045544

Questions about this trial

What is this clinical trial studying?

A study testing Catfish and Solitaire FR in people with Acute Ischemic Stroke, run by Ministry of Science and Technology of the People´s Republic of China at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Instant recanalization rate (mTICI 2b-3) of target vessel after the procedure (time frame: immediate). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03820882, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2022.

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