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

The Efficacy and Safety Study of Stent Retriever's(TonbridgeMT) Endovascular Therapy for Acute Ischemic Stroke

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™.

Study Overview

• Status: Completed
• Conditions: Ischemic Stroke
• Intervention / Treatment: Device: stent retriever(TonbridgeMT); Device: 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.

• Study Type: Interventional
• Enrollment (Actual): 220
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • The 306th Hospital of Chinese PLA
  • Changchun, China
    • The First Hospital of Jilin University
  • Changchun, China
    • China-Japan Union Hospital
  • Changzhou, China
    • The First People's Hospital of Changzhou
  • Guangzhou, China
    • The Second Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine
  • Guiyang, China
    • The Affiliated Hospital of Guizhou Medical University
  • Hangzhou, China
    • Hangzhou First People's Hospital
  • Hanzhou, China
    • The Second Affiliated Hospital of Zhejiang University School of Medicine
  • Nanjing, China
    • Nanjing First Hospital Affiliated to Nanjing Medicine University
  • Nanning, China
    • Nanning People's Hospital
  • Wuhan, China
    • The Third People's Hospital of Hubei Province
  • Xi'an, China
    • Tangdu Hospital
  • Zhengzhou, China
    • Henan Provincial People's Hospital
  • Zhengzhou, China
    • the First Affiliated Hospital of Zhengzhou University
  • Zhongshan, China
    • Zhongshan People's Hospital
  • Zhuhai, China
    • The Fifth Affiliated Hospital Sun Yat-Sen University
  • Shanghai
    • Shanghai, Shanghai, China
      • Changhai Hospital of Shanghai

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: group A; subjects applying the stent retriever(TonbridgeMT)	Device: stent retriever(TonbridgeMT); mechanical thrombectomy with stent retriever(TonbridgeMT), digital subtraction angiography(DSA), computed tomography(CT), magnetic resonance imaging (MRI), diffusion weighted imaging (DWI)
Active Comparator: group B; subjects applying Solitaire™	Device: Solitaire™; mechanical thrombectomy with Solitaire™ , digital subtraction angiography(DSA), computed tomography(CT), magnetic resonance imaging(MRI), diffusion weighted imaging(DWI)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	intraoperative immediate

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
successful recanalization rate in vessels	The proportion of successful recanalized vessels in all targeted vessels which receive the stent retriever treatment	intraoperative immediate
Time to achieve recanalization	The period from femoral artery puncture to successful recanalization	intraoperative immediate
NIHSS score	National Institutes of Health Stroke Scale	baseline, 24±6d and 7±2d after operation
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.	baseline, 90±14d after operation
the ratio of mRS 0-2	The proportion of patients who got a mRS 0-2 in patients who receive stent retriever treatment	baseline, 90±14d after operation
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	intraoperative immediate

Collaborators and Investigators

• Sponsor: Zhuhai Tonbridge Medical Tech. Co., Ltd.
• Collaborators: Guangzhou Osmunda Medical Device Technology, Inc., Ltd.

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 3, 2017
• Primary Completion (Actual): August 27, 2018
• Study Completion (Actual): August 27, 2018

Study Registration Dates

• First Submitted: July 2, 2017
• First Submitted That Met QC Criteria: July 4, 2017
• First Posted (Actual): July 7, 2017

Study Record Updates

• Last Update Posted (Actual): September 12, 2018
• Last Update Submitted That Met QC Criteria: September 10, 2018
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Ischemia; Infarction; Brain Infarction; Stroke; Ischemic Stroke; Ischemia; Cerebral Infarction
• Other Study ID Numbers: JCQ-B-010

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No