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

Ischemic Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03210623
• Other study ID #: JCQ-B-010
• Status: Completed
• Phase: N/A
• Start date: August 3, 2017
• Est. completion date: August 27, 2018

Study information

• Verified date: June 2017
• Source: Zhuhai Tonbridge Medical Tech. Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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™.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: August 27, 2018
• Est. primary completion date: August 27, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Stroke

Intervention

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

Locations

Country	Name	City	State
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	Changhai Hospital of Shanghai	Shanghai	Shanghai
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

Sponsors (2)

Lead Sponsor	Collaborator
Zhuhai Tonbridge Medical Tech. Co., Ltd.	Guangzhou Osmunda Medical Device Technology, Inc., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	successful recanalization rate in vessels	The proportion of successful recanalized vessels in all targeted vessels which receive the stent retriever treatment	intraoperative immediate
Secondary	Time to achieve recanalization	The period from femoral artery puncture to successful recanalization	intraoperative immediate
Secondary	NIHSS score	National Institutes of Health Stroke Scale	baseline, 24±6d and 7±2d after operation
Secondary	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
Secondary	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
Secondary	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