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Stent Retriever's(TonbridgeMT) Endovascular Therapy for Acute Ischemic Stroke(AIS)

Primary Purpose

Ischemic Stroke

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
stent retriever(TonbridgeMT)
Solitaire™
Sponsored by
Zhuhai Tonbridge Medical Tech. Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ischemic Stroke

Eligibility Criteria

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

Inclusion Criteria:

  1. 18≤ages≤80;
  2. Baseline NIHSS score obtained prior to randomization must be lower than 30 points;
  3. Acute occlusion(TICI 0-1) of the intracranial segment of internal carotid artery(ICA), or M1/M2 middle cerebral artery(MCA), or A1/A2 anterior cerebral artery(ACA), as evidenced by digital subtraction angiography(DSA);
  4. Patient treatable within 6 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;
  5. Pre-AIS mRS score lower than 2.

Exclusion Criteria:

  1. Computed tomography (CT) or magnetic resonance imaging (MRI) evidence of intracranial hemorrhage or massive cerebral infarction (ASPECTS score of<6 or infarct volume≥70ml or volume>1/3 blood supplying areas of MCA on CT/diffusion weighted imaging(DWI);
  2. DSA evidence of simultaneous acute bilateral carotid occlusion;
  3. DSA evidence of occlusions in the initial segment of carotid artery or carotid artery dissection or arteritis;
  4. DSA evidence of tortuosity of cervical vessels precluding device delivery/deployment;
  5. Hypertension (Systolic blood pressure(SBP)>185 mm Hg or diastolic blood pressure(DBP)>110 mm Hg) after using drug;
  6. Platelet count<40,000/μL and use of Novel Anticoagulant with International Normalized Ratio(INR)>3.0;
  7. Random blood glucose of<2.7mmol/L or>22.2mmol/L;
  8. 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, myocardial infarction within the past 12 months before enrollment, history of sever psychosis);
  9. Patients who will not cooperate or tolerate interventional operation;
  10. Anticipated life expectancy of less than 90 days;
  11. Allergy to contrast medium;
  12. Females who are pregnant or breastfeeding;
  13. Participation in any other clinical trial within the past 1 months before screening and follow-up;
  14. The patient or the patient's legally authorized representative hasn't signed and dated an informed consent form;
  15. Other factors that would cause harm or increased risk to the participant or close contacts, or preclude the participant's full adherence as per investigator's judgement.

Sites / Locations

  • Changhai Hospital of Shanghai
  • The 306th Hospital of Chinese PLA
  • China-Japan union hospital
  • The First Hospital of Jilin University
  • The First People's Hospital of Changzhou
  • The Second Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine
  • The Affiliated Hospital of Guizhou Medical University
  • Hangzhou First People's Hospital
  • The Second Affiliated hospital of Zhejiang University School of Medicine
  • Nanjing First Hospital Affiliated to Nanjing Medicine University
  • Nanning People's Hospital
  • The Third People's Hospital of Hubei Province
  • Tangdu Hospital
  • Henan Provincial People's Hospital
  • The First Affiliated Hospital of Zhengzhou University
  • Zhongshan People's Hospital
  • The Fifth Affiliated Hospital Sun Yat-sen University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

group A

group B

Arm Description

subjects applying the stent retriever(TonbridgeMT)

subjects applying Solitaire™

Outcomes

Primary Outcome Measures

successful recanalization rate in patients
Successful recanalization is defined as modified Thrombolysis In Cerebral Ischemia scale 2b or 3. And it is evaluated by DSA intraoperative immediately in both treatment groups

Secondary Outcome Measures

successful recanalization rate in vessels
The proportion of successful recanalized vessels in all targeted vessels which receive the stent retriever treatment
Time to achieve recanalization
The period from femoral artery puncture to successful recanalization
NIHSS score
National Institutes of Health Stroke Scale
mRS score
The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability.
the ratio of mRS 0-2
The proportion of patients who got a mRS 0-2 in patients who receive stent retriever treatment
transportation performance
The proportion of stent retriever which can push and draw back well during the operation. The operator will grade each stent retriever at four level, namely great， good， average，and bad

Full Information

First Posted
July 2, 2017
Last Updated
September 10, 2018
Sponsor
Zhuhai Tonbridge Medical Tech. Co., Ltd.
Collaborators
Guangzhou Osmunda Medical Device Technology, Inc., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03210623
Brief Title
Stent Retriever's(TonbridgeMT) Endovascular Therapy for Acute Ischemic Stroke(AIS)
Official Title
The Efficacy and Safety Study of Stent Retriever's(TonbridgeMT) Endovascular Therapy for Acute Ischemic Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
August 3, 2017 (Actual)
Primary Completion Date
August 27, 2018 (Actual)
Study Completion Date
August 27, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zhuhai Tonbridge Medical Tech. Co., Ltd.
Collaborators
Guangzhou Osmunda Medical Device Technology, Inc., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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(TonbridgeMT) or Solitaire™ for endovascular therapy for AIS. The study aims to evaluate the benefit and safety of stent retriever(TonbridgeMT) for AIS therapy, as compared to Solitaire™.
Detailed Description
The main objective is to determine whether stent retriever(TonbridgeMT) will have non-inferior successful recanalization rate compared to Solitaire™ when applied to endovascular therapy for AIS. The secondary objectives is to verify whether there isn't significant differences in time to achieve recanalization, NIHSS score, mRS score, and transportation performance between stent retriever(TonbridgeMT) and Solitaire™ when applied to endovascular therapy for AIS. The third objectives is to verify whether there isn't significant differences in the rate of symptomatic intracranial hemorrhage, subarachnoid hemorrhage, adverse event(AE), serious adverse event(SAE), actual condition of AE and device deficiencies between stent retriever(TonbridgeMT) and Solitaire™ when applied to endovascular therapy for AIS.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
prospective, stratified-randomized, single-blind, parallel assignment, active control
Masking
Participant
Allocation
Randomized
Enrollment
220 (Actual)

8. Arms, Groups, and Interventions

Arm Title
group A
Arm Type
Experimental
Arm Description
subjects applying the stent retriever(TonbridgeMT)
Arm Title
group B
Arm Type
Active Comparator
Arm Description
subjects applying Solitaire™
Intervention Type
Device
Intervention Name(s)
stent retriever(TonbridgeMT)
Intervention Description
mechanical thrombectomy with stent retriever(TonbridgeMT), digital subtraction angiography(DSA), computed tomography(CT), magnetic resonance imaging (MRI), diffusion weighted imaging (DWI)
Intervention Type
Device
Intervention Name(s)
Solitaire™
Intervention Description
mechanical thrombectomy with Solitaire™ , digital subtraction angiography(DSA), computed tomography(CT), magnetic resonance imaging(MRI), diffusion weighted imaging(DWI)
Primary Outcome Measure Information:
Title
successful recanalization rate in patients
Description
Successful recanalization is defined as modified Thrombolysis In Cerebral Ischemia scale 2b or 3. And it is evaluated by DSA intraoperative immediately in both treatment groups
Time Frame
intraoperative immediate
Secondary Outcome Measure Information:
Title
successful recanalization rate in vessels
Description
The proportion of successful recanalized vessels in all targeted vessels which receive the stent retriever treatment
Time Frame
intraoperative immediate
Title
Time to achieve recanalization
Description
The period from femoral artery puncture to successful recanalization
Time Frame
intraoperative immediate
Title
NIHSS score
Description
National Institutes of Health Stroke Scale
Time Frame
baseline, 24±6d and 7±2d after operation
Title
mRS score
Description
The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability.
Time Frame
baseline, 90±14d after operation
Title
the ratio of mRS 0-2
Description
The proportion of patients who got a mRS 0-2 in patients who receive stent retriever treatment
Time Frame
baseline, 90±14d after operation
Title
transportation performance
Description
The proportion of stent retriever which can push and draw back well during the operation. The operator will grade each stent retriever at four level, namely great， good， average，and bad
Time Frame
intraoperative immediate

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18≤ages≤80; Baseline NIHSS score obtained prior to randomization must be lower than 30 points; Acute occlusion(TICI 0-1) of the intracranial segment of internal carotid artery(ICA), or M1/M2 middle cerebral artery(MCA), or A1/A2 anterior cerebral artery(ACA), as evidenced by digital subtraction angiography(DSA); Patient treatable within 6 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; Pre-AIS mRS score lower than 2. Exclusion Criteria: Computed tomography (CT) or magnetic resonance imaging (MRI) evidence of intracranial hemorrhage or massive cerebral infarction (ASPECTS score of<6 or infarct volume≥70ml or volume>1/3 blood supplying areas of MCA on CT/diffusion weighted imaging(DWI); DSA evidence of simultaneous acute bilateral carotid occlusion; DSA evidence of occlusions in the initial segment of carotid artery or carotid artery dissection or arteritis; DSA evidence of tortuosity of cervical vessels precluding device delivery/deployment; Hypertension (Systolic blood pressure(SBP)>185 mm Hg or diastolic blood pressure(DBP)>110 mm Hg) after using drug; Platelet count<40,000/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, myocardial infarction within the past 12 months before enrollment, history of sever psychosis); Patients who will not cooperate or tolerate interventional operation; Anticipated life expectancy of less than 90 days; Allergy to contrast medium; Females who are pregnant or breastfeeding; Participation in any other clinical trial within the past 1 months before screening and follow-up; The patient or the patient's legally authorized representative hasn't signed and dated an informed consent form; Other factors that would cause harm or increased risk to the participant or close contacts, or preclude the participant's full adherence as per investigator's judgement.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jianmin Liu
Organizational Affiliation
Changhai Hospital of Shangha
Official's Role
Principal Investigator
Facility Information:
Facility Name
Changhai Hospital of Shanghai
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
The 306th Hospital of Chinese PLA
City
Beijing
Country
China
Facility Name
China-Japan union hospital
City
Changchun
Country
China
Facility Name
The First Hospital of Jilin University
City
Changchun
Country
China
Facility Name
The First People's Hospital of Changzhou
City
Changzhou
Country
China
Facility Name
The Second Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine
City
Guangzhou
Country
China
Facility Name
The Affiliated Hospital of Guizhou Medical University
City
Guiyang
Country
China
Facility Name
Hangzhou First People's Hospital
City
Hangzhou
Country
China
Facility Name
The Second Affiliated hospital of Zhejiang University School of Medicine
City
Hanzhou
Country
China
Facility Name
Nanjing First Hospital Affiliated to Nanjing Medicine University
City
Nanjing
Country
China
Facility Name
Nanning People's Hospital
City
Nanning
Country
China
Facility Name
The Third People's Hospital of Hubei Province
City
Wuhan
Country
China
Facility Name
Tangdu Hospital
City
Xi'an
Country
China
Facility Name
Henan Provincial People's Hospital
City
Zhengzhou
Country
China
Facility Name
The First Affiliated Hospital of Zhengzhou University
City
Zhengzhou
Country
China
Facility Name
Zhongshan People's Hospital
City
Zhongshan
Country
China
Facility Name
The Fifth Affiliated Hospital Sun Yat-sen University
City
Zhuhai
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34456847
Citation
Zhang Y, Hua W, Li Z, Peng Y, Han Z, Li T, Yin C, Wang S, Nan G, Zhao Z, Yang H, Zhou B, Li T, Cai Y, Zhang J, Li G, Peng X, Guan S, Zhou J, Ye M, Wang L, Zhang L, Hong B, Zhang Y, Wan J, Wang Y, Zhu Q, Liu J, Yang P. Efficacy and Safety of a Novel Thrombectomy Device in Patients With Acute Ischemic Stroke: A Randomized Controlled Trial. Front Neurol. 2021 Aug 12;12:686253. doi: 10.3389/fneur.2021.686253. eCollection 2021.
Results Reference
derived

Learn more about this trial

Stent Retriever's(TonbridgeMT) Endovascular Therapy for Acute Ischemic Stroke(AIS)

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