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
1 other identifier
interventional
220
1 country
17
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™.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2017
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 2, 2017
CompletedFirst Posted
Study publicly available on registry
July 7, 2017
CompletedStudy Start
First participant enrolled
August 3, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 27, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 27, 2018
CompletedSeptember 12, 2018
June 1, 2017
1.1 years
July 2, 2017
September 10, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (6)
successful recanalization rate in vessels
intraoperative immediate
Time to achieve recanalization
intraoperative immediate
NIHSS score
baseline, 24±6d and 7±2d after operation
mRS score
baseline, 90±14d after operation
the ratio of mRS 0-2
baseline, 90±14d after operation
- +1 more secondary outcomes
Study Arms (2)
group A
EXPERIMENTALsubjects applying the stent retriever(TonbridgeMT)
group B
ACTIVE COMPARATORsubjects applying Solitaire™
Interventions
mechanical thrombectomy with stent retriever(TonbridgeMT), digital subtraction angiography(DSA), computed tomography(CT), magnetic resonance imaging (MRI), diffusion weighted imaging (DWI)
mechanical thrombectomy with Solitaire™ , digital subtraction angiography(DSA), computed tomography(CT), magnetic resonance imaging(MRI), diffusion weighted imaging(DWI)
Eligibility Criteria
You may qualify if:
- ≤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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
Changhai Hospital of Shanghai
Shanghai, Shanghai Municipality, China
The 306th Hospital of Chinese PLA
Beijing, China
China-Japan union hospital
Changchun, China
The First Hospital of Jilin University
Changchun, China
The First People's Hospital of Changzhou
Changzhou, China
The Second Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine
Guangzhou, China
The Affiliated Hospital of Guizhou Medical University
Guiyang, China
Hangzhou First People's Hospital
Hangzhou, China
The Second Affiliated hospital of Zhejiang University School of Medicine
Hanzhou, China
Nanjing First Hospital Affiliated to Nanjing Medicine University
Nanjing, China
Nanning People's Hospital
Nanning, China
The Third People's Hospital of Hubei Province
Wuhan, China
Tangdu Hospital
Xi'an, China
Henan Provincial People's Hospital
Zhengzhou, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, China
Zhongshan People's Hospital
Zhongshan, China
The Fifth Affiliated Hospital Sun Yat-sen University
Zhuhai, China
Related Publications (1)
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.
PMID: 34456847DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jianmin Liu
Changhai Hospital of Shangha
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 2, 2017
First Posted
July 7, 2017
Study Start
August 3, 2017
Primary Completion
August 27, 2018
Study Completion
August 27, 2018
Last Updated
September 12, 2018
Record last verified: 2017-06
Data Sharing
- IPD Sharing
- Will not share