Clinical trial NCT03210623: 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
Overall status: COMPLETED
Phase: NA
Conditions: Ischemic Stroke
Lead sponsor: Ton-Bridge Medical Tech. Co., Ltd
Sponsor class: INDUSTRY
Collaborators: name: Guangzhou Osmunda Medical Device Technology, Inc., Ltd.
First posted: 2017-07-07
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective, stratified-randomized, single-blind, parallel assignment, active control
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: successful recanalization rate in patients
timeFrame: intraoperative immediate
Secondary outcomes:
measure: successful recanalization rate in vessels
timeFrame: intraoperative immediate
measure: Time to achieve recanalization
timeFrame: intraoperative immediate
measure: NIHSS score
timeFrame: baseline, 24±6d and 7±2d after operation
measure: mRS score
timeFrame: baseline, 90±14d after operation
measure: the ratio of mRS 0-2
timeFrame: baseline, 90±14d after operation
measure: transportation performance
timeFrame: intraoperative immediate
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Changhai Hospital of Shanghai
state: Shanghai
city: Beijing
country: China
facility: The 306th Hospital of Chinese PLA
city: Changchun
country: China
facility: China-Japan union hospital
city: Changchun
country: China
facility: The First Hospital of Jilin University
city: Changzhou
country: China
facility: The First People's Hospital of Changzhou
city: Guangzhou
country: China
facility: The Second Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine
city: Guiyang
country: China
facility: The Affiliated Hospital of Guizhou Medical University
city: Hangzhou
country: China
facility: Hangzhou First People's Hospital
city: Hanzhou
country: China
facility: The Second Affiliated hospital of Zhejiang University School of Medicine
city: Nanjing
country: China
facility: Nanjing First Hospital Affiliated to Nanjing Medicine University
city: Nanning
country: China
facility: Nanning People's Hospital
city: Wuhan
country: China
facility: The Third People's Hospital of Hubei Province
city: Xi'an
country: China
facility: Tangdu Hospital
city: Zhengzhou
country: China
facility: Henan Provincial People's Hospital
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
city: Zhongshan
country: China
facility: Zhongshan People's Hospital
city: Zhuhai
country: China
facility: The Fifth Affiliated Hospital Sun Yat-sen University
Study officials:
affiliation: Changhai Hospital of Shangha
name: Jianmin Liu
role: PRINCIPAL_INVESTIGATOR
References:
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.