A Single-Arm Objective Performance Criteria Trial for Intracranial Thrombus Aspiration Catheter
NCT ID: NCT05119647
Last Updated: 2024-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
124 participants
INTERVENTIONAL
2022-02-11
2022-11-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Aspiration thrombectomy
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.
Thrombus Aspiration Catheter(Ton-bridgeMT)
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.
Interventions
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Thrombus Aspiration Catheter(Ton-bridgeMT)
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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 .
18 Years
85 Years
ALL
No
Sponsors
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Ton-Bridge Medical Tech. Co., Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Liqun Jiao
Role: PRINCIPAL_INVESTIGATOR
Xuanwu Hospital, Beijing
Locations
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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
Ganzhou Municipal Hospital
Ganzhou, Jiangxi, 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
Countries
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Other Identifiers
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ZHTQ2021001
Identifier Type: -
Identifier Source: org_study_id
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