Back to results

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

Primary Purpose

Acute Ischemic Stroke

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Catfish

Solitaire FR

About this trial

This is an interventional treatment trial for Acute Ischemic Stroke

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.
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.

Sites / Locations

Beijing Tiantan hospital, Capital Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

stent retriever(Catfish)

stent retriever(Solitaire FR)

Arm Description

Mechanical thrombectomy with Catfish flow restoration device

Mechanical thrombectomy with Solitaire FR flow restoration device

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Time to achieve recanalization

The period from femoral artery puncture to successful recanalization

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

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

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)

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

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

all cause of mortality within 90±14 days after procedure

Full Information

NCT ID

NCT03820882

First Posted

January 14, 2019

Last Updated

September 23, 2022

Sponsor

Ministry of Science and Technology of the People´s Republic of China

1. Study Identification

Unique Protocol Identification Number

NCT03820882

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Completed

Study Start Date

March 3, 2019 (Actual)

Primary Completion Date

January 5, 2021 (Actual)

Study Completion Date

June 5, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ministry of Science and Technology of the People´s Republic of China

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Ischemic Stroke

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

prospective, randomized, open-label, parallel assignment

Masking

InvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

238 (Actual)

8. Arms, Groups, and Interventions

Arm Title

stent retriever(Catfish)

Arm Type

Experimental

Arm Description

Mechanical thrombectomy with Catfish flow restoration device

Arm Title

stent retriever(Solitaire FR)

Arm Type

Active Comparator

Arm Description

Mechanical thrombectomy with Solitaire FR flow restoration device

Intervention Type

Device

Intervention Name(s)

Catfish

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

Solitaire FR

Intervention Description

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

Primary Outcome Measure Information:

Title

Instant recanalization rate (mTICI 2b-3) of target vessel after the procedure

Description

Time Frame

immediate

Secondary Outcome Measure Information:

Title

Time to achieve recanalization

Description

The period from femoral artery puncture to successful recanalization

Time Frame

intraprocedure immediate

Title

NIHSS score at 24±2 hours

Description

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

Time Frame

24±2 hours

Title

NIHSS score at 7±1 days or discharge

Description

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

Time Frame

7±1 days

Title

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

Description

Time Frame

90±14 days

Title

symptomatic intracranial hemorrhage after procedure

Description

Time Frame

24±2 hours

Title

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

Time Frame

90±14 days

Title

all cause of mortality within 90±14 days after procedure

Time Frame

90±14 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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. 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Zhongrong Miao, MD

Organizational Affiliation

Beijing Tiantan Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Beijing Tiantan hospital, Capital Medical University

City

Beijing

State/Province

Beijing

ZIP/Postal Code

10000

Country

China

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs