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

NCT ID: NCT03210623

Last Updated: 2018-09-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 220 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-03
• Study Completion Date: 2018-08-27

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.

Conditions

Ischemic Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

group A

subjects applying the stent retriever(TonbridgeMT)

Group Type: EXPERIMENTAL

stent retriever(TonbridgeMT)

Intervention Type: DEVICE

mechanical thrombectomy with stent retriever(TonbridgeMT), digital subtraction angiography(DSA), computed tomography(CT), magnetic resonance imaging (MRI), diffusion weighted imaging (DWI)

group B

subjects applying Solitaire™

Group Type: ACTIVE_COMPARATOR

Solitaire™

Intervention Type: DEVICE

mechanical thrombectomy with Solitaire™ , digital subtraction angiography(DSA), computed tomography(CT), magnetic resonance imaging(MRI), diffusion weighted imaging(DWI)

Interventions

stent retriever(TonbridgeMT)

mechanical thrombectomy with stent retriever(TonbridgeMT), digital subtraction angiography(DSA), computed tomography(CT), magnetic resonance imaging (MRI), diffusion weighted imaging (DWI)

Intervention Type: DEVICE

Solitaire™

mechanical thrombectomy with Solitaire™ , digital subtraction angiography(DSA), computed tomography(CT), magnetic resonance imaging(MRI), diffusion weighted imaging(DWI)

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Guangzhou Osmunda Medical Device Technology, Inc., Ltd.

INDUSTRY

Sponsor Role: collaborator

Ton-Bridge Medical Tech. Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jianmin Liu

Role: PRINCIPAL_INVESTIGATOR

Changhai Hospital of Shangha

Locations

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

Countries

China

References

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.

Reference Type: DERIVED

PMID: 34456847 (View on PubMed)

Other Identifiers

JCQ-B-010

Identifier Type: -

Identifier Source: org_study_id