A Single-Arm Objective Performance Criteria Trial For Intracranial Thrombus Aspiration Catheter

Study Overview
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Brief Summary
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This is a prospective multicenter, single-arm objective performance criteria trial to assess the efficacy and safety of the the thrombus aspiration catheter.

Detailed Description
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The study is conducted in 15 centers all around China, aiming at recruiting 155 patients with acute stroke caused by artery occlusion.

Official Title
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The Efficacy and Safety Study of Thrombus Aspiration Catheter(Ton-bridgeMT) on Endovascular Treatment of Acute Ischemic Stroke

Conditions
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Acute Ischemic Stroke

Intervention / Treatment
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* Device: Thrombus Aspiration Catheter(Ton-bridgeMT)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥18 years; Baseline NIHSS score ≥6; Subject has acute occlusion located in Vertebral artery(VA) / Internal Carotid Artery (ICA) / M1or M2 segment of Middle Cerebral Artery (MCA) / Basilar artery (BA) diagnosed by DSA; Femoral artery puncture is expected to be completed within 24 hours of onset； mRS score≤ 2; Subject or legal representative is able to understand the purpose of study, agrees to comply with protocol requirements and has provided written informed consent. Exclusion Criteria: Chronic occlusion in the target area; Epilepsy at the time of stroke； Bleeding from the gastrointestinal or urinary system in the past three weeks； After drug control, systolic blood pressure was greater than 185mmhg and / or diastolic blood pressure was greater than 110mmhg; International Normalized Ratio(INR)>3; Random blood glucose < 2.7mmol/L or > 22.2mmol/L; Heart, lung, liver, kidney failure or other serious diseases (such as brain tumors, - systemic infection, active disseminated intravascular coagulation, myocardial infarction within 12 months before enrollment, history of severe mental illness); Tortuous lesion / severe stenosis in the starting segment of the carotid artery / Carotid dissection / Arteritis judged by researchers that is not suitable for the procedure; Acute occlusion of bilateral carotid arteries； Intracranial hemorrhage or massive infarction diagnosed by CT or MR; History of allergies to antiplatelet drugs, anticoagulants, anesthetics, contrast agents; Expected life <12 months; Female subjects who are pregnant or planning to become pregnant or lactate within the study period; Subject has participated in any other drug or medical device clinical trials in 1 month before signing informed consent; Other circumstances judged by researchers that are not suitable for enrollment .

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Patient Recruited<br>Since this is a single-arm objective performance criteria trial, patients with acute stoke caused by artery occlusion shall not be divided into two groups. | Device: Thrombus Aspiration Catheter(Ton-bridgeMT)<br>* Thrombus Aspiration Catheter is a developed technique for treating acute stroke caused by artery occlusion. The catheter(Ton-bridgeMT) was specially designed for those patients who experience acute stroke within 24 hours.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful recanalization rate within three-times aspiration | Successful recanalization is defined as modified Thrombolysis In Cerebral Infarction scale(mTICI) 2b or 3 evaluated by Digital subtraction angiography (DSA). | Up to 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful recanalization rate within three-times aspiration | Successful recanalization is defined as mTICI 2b or 3 evaluated by DSA. | Intraoperation | 
| Successful recanalization rate beyond three-times aspiration | Successful recanalization is defined as mTICI 2b or 3 evaluated by DSA. Auxiliary device such as stent could be used. | Intraoperation | 
| National Institute of Health stroke scale(NIHSS) | NIHSS score in 72 hours and 7 days(or the day when patients discharged, depends on which day is earlier) will be compared. | 72 hours / 7 days | 
| Rate of Modified Rankin Scale(mRS) score less than 3 | The mRS score is assessed in 90 days follow-up. | 90 days | 
| Device delivery performance | Device delivery performance including transport and pullback performance, which is ranked excellent/good/normal/bad. | Intraoperation | 
| The rate of symptomatic intracranial hemorrhage | National Institute of Health stroke scale(NIHSS) increased by at least 4 compared with the baseline. | 72 hours | 
| Death rate | Subjects who died from any cause would be counted. | Up to 90 days | 
| The rate of AE | The definition of AE(Adverse Event) refers to ISO 14155 | Up to 90 days | 
| The rate of SAE | The definition of SAE (Serious Adverse Event) refers to ISO 14155 | Up to 90 days | 
| The rate of medical device deficiency | Medical device deficiency refer to the unreasonable risks of medical devices that may endanger human health and life safety under normal use in the process of clinical trials, such as label errors, quality problems, malfunctions, etc. | Up to 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke, Aspiration, Catheter, Intracranial