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

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

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

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

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 .