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

Zhuhai Tonbridge Medical Technology

Status: Completed

Conditions: Acute Ischemic Stroke

Treatments: Device: Thrombus Aspiration Catheter(Ton-bridgeMT)

Study type: Interventional

Funder types: Industry

Identifiers

NCT05119647

ZHTQ2021001

Details and patient eligibility

About

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

Full description

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

Enrollment: 124 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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 .

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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124 participants in 1 patient group

Aspiration thrombectomy

Experimental group

Description:

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.

Treatment:

Device: Thrombus Aspiration Catheter(Ton-bridgeMT)