A Single-Arm Objective Performance Criteria Trial For Intracranial Thrombus Aspiration Catheter
- Conditions
- Acute Ischemic Stroke
- Interventions
- Device: Thrombus Aspiration Catheter(Ton-bridgeMT)
- Registration Number
- NCT05119647
- Lead Sponsor
- Zhuhai Tonbridge Medical Tech. Co., Ltd.
- Brief Summary
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
The study is conducted in 15 centers all around China, aiming at recruiting 155 patients with acute stroke caused by artery occlusion.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 155
- 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.
- 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 .
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Aspiration thrombectomy Thrombus Aspiration Catheter(Ton-bridgeMT) 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.
- Primary Outcome Measures
Name Time Method Successful recanalization rate within three-times aspiration Up to 90 days Successful recanalization is defined as modified Thrombolysis In Cerebral Infarction scale(mTICI) 2b or 3 evaluated by Digital subtraction angiography (DSA).
- Secondary Outcome Measures
Name Time Method The rate of SAE Up to 90 days The definition of SAE (Serious Adverse Event) refers to ISO 14155
The rate of AE Up to 90 days The definition of AE(Adverse Event) refers to ISO 14155
Device delivery performance Intraoperation Device delivery performance including transport and pullback performance, which is ranked excellent/good/normal/bad.
Death rate Up to 90 days Subjects who died from any cause would be counted.
Successful recanalization rate beyond three-times aspiration Intraoperation Successful recanalization is defined as mTICI 2b or 3 evaluated by DSA. Auxiliary device such as stent could be used.
Rate of Modified Rankin Scale(mRS) score less than 3 90 days The mRS score is assessed in 90 days follow-up.
Successful recanalization rate within three-times aspiration Intraoperation Successful recanalization is defined as mTICI 2b or 3 evaluated by DSA.
National Institute of Health stroke scale(NIHSS) 72 hours / 7 days NIHSS score in 72 hours and 7 days(or the day when patients discharged, depends on which day is earlier) will be compared.
The rate of symptomatic intracranial hemorrhage 72 hours National Institute of Health stroke scale(NIHSS) increased by at least 4 compared with the baseline.
The rate of medical device deficiency Up to 90 days 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.
Trial Locations
- Locations (15)
Ganzhou Municipal Hospital
🇨🇳Ganzhou, Jiangxi, China
The First Affiliated Hospital of USTC
🇨🇳Hefei, Anhui, China
Zhuhai people's hospital
🇨🇳Zhuhai, Guangdong, China
The Second Nanning People's hospital
🇨🇳Nanning, Guangxi, China
Cangzhou central hospital
🇨🇳Cangzhou, Hebei, China
Hunan Provincial People's Hospital
🇨🇳Changsha, Hunan, China
Central Hospital Affiliated to Shangdong First Medical University
🇨🇳Jinan, Shandong, China
First People's Hospital of Jinan
🇨🇳Jinan, Shandong, China
The Second People's Hospital of Liaocheng
🇨🇳Liaocheng, Shandong, China
Rizhao central Hospital
🇨🇳Rizhao, Shandong, China
Shanxi Candiovascular hospital
🇨🇳Taiyuan, Shanxi, China
School of medicine UESTC
🇨🇳Chengdu, Sichuan, China
Zigong Third People's Hospital
🇨🇳Zigong, Sichuan, China
The Second Affiliated Hospital of Zhejiang University School of Medicine
🇨🇳Hangzhou, Zhejiang, China
Xuanwu hospital Capital Medical University
🇨🇳Beijing, China