Clinical trial NCT05119647: A Single-Arm Objective Performance Criteria Trial for Intracranial Thrombus Aspiration Catheter
Official title: The Efficacy and Safety Study of Thrombus Aspiration Catheter(Ton-bridgeMT) on Endovascular Treatment of Acute Ischemic Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Ischemic Stroke
Keywords: Stroke
Aspiration
Catheter
Intracranial
Lead sponsor: Ton-Bridge Medical Tech. Co., Ltd
Sponsor class: INDUSTRY
First posted: 2021-11-15
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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 .

Primary outcomes:
measure: Successful recanalization rate within three-times aspiration
timeFrame: Up to 90 days
Secondary outcomes:
measure: Successful recanalization rate within three-times aspiration
timeFrame: Intraoperation
measure: Successful recanalization rate beyond three-times aspiration
timeFrame: Intraoperation
measure: National Institute of Health stroke scale(NIHSS)
timeFrame: 72 hours / 7 days
measure: Rate of Modified Rankin Scale(mRS) score less than 3
timeFrame: 90 days
measure: Device delivery performance
timeFrame: Intraoperation
measure: The rate of symptomatic intracranial hemorrhage
timeFrame: 72 hours
measure: Death rate
timeFrame: Up to 90 days
measure: The rate of AE
timeFrame: Up to 90 days
measure: The rate of SAE
timeFrame: Up to 90 days
measure: The rate of medical device deficiency
timeFrame: Up to 90 days
Other outcomes:
Locations:
city: Hefei
country: China
facility: The First Affiliated Hospital of USTC
state: Anhui
city: Zhuhai
country: China
facility: Zhuhai people's hospital
state: Guangdong
city: Nanning
country: China
facility: The Second Nanning People's hospital
state: Guangxi
city: Cangzhou
country: China
facility: Cangzhou central hospital
state: Hebei
city: Changsha
country: China
facility: Hunan Provincial People's Hospital
state: Hunan
city: Ganzhou
country: China
facility: Ganzhou Municipal Hospital
state: Jiangxi
city: Jinan
country: China
facility: Central Hospital Affiliated to Shangdong First Medical University
state: Shandong
city: Jinan
country: China
facility: First People's Hospital of Jinan
state: Shandong
city: Liaocheng
country: China
facility: The Second People's Hospital of Liaocheng
state: Shandong
city: Rizhao
country: China
facility: Rizhao central Hospital
state: Shandong
city: Taiyuan
country: China
facility: Shanxi Candiovascular hospital
state: Shanxi
city: Chengdu
country: China
facility: School of medicine UESTC
state: Sichuan
city: Zigong
country: China
facility: Zigong Third People's Hospital
state: Sichuan
city: Hangzhou
country: China
facility: The Second Affiliated Hospital of Zhejiang University School of Medicine
state: Zhejiang
city: Beijing
country: China
facility: Xuanwu hospital Capital Medical University
Study officials:
affiliation: Xuanwu Hospital, Beijing
name: Liqun Jiao
role: PRINCIPAL_INVESTIGATOR
References: