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.

Study Overview

• Status: Not yet recruiting
• Conditions: Acute Ischemic Stroke
• Intervention / Treatment: Device: Thrombus Aspiration Catheter(Ton-bridgeMT)

Detailed Description

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

• Study Type: Interventional
• Enrollment (Anticipated): 155
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dingrong Pan; Phone Number: 18868106641; Email: dr.pan@ton-bridge.com
• Study Contact Backup: Name: Peiyi Li; Phone Number: 13840536851; Email: py.li@ton-bridge.com

Study Locations

• China
  • Beijing, China
    • Xuanwu Hospital Capital Medical University
    • Contact: Liqun Jiao
  • Anhui
    • Hefei, Anhui, China
      • The First Affiliated hospital of USTC
  • Guangdong
    • Zhuhai, Guangdong, China
      • Zhuhai People's Hospital
      • Contact: Ligong Lu
  • Guangxi
    • Nanning, Guangxi, China
      • The Second Nanning People's Hospital
      • Contact: Tong Li
  • Hebei
    • Cangzhou, Hebei, China
      • Cangzhou Central Hospital
      • Contact: Yongchang Liu
  • Hunan
    • Changsha, Hunan, China
      • Hunan Provincial People's Hospital
      • Contact: Hua Xiang
  • Jiangxi
    • Ganzhou, Jiangxi, China
      • Ganzhou Municipal Hospital
      • Contact: Hanwen Liu
  • Shandong
    • Jinan, Shandong, China
      • Central Hospital Affiliated to Shangdong First Medical University
      • Contact: Yanxin Zhao
    • Jinan, Shandong, China
      • First People's Hospital of Jinan
      • Contact: Jianfeng Chu
    • Liaocheng, Shandong, China
      • The Second People's Hospital of Liaocheng
      • Contact: Xinqiang Wang
    • Rizhao, Shandong, China
      • Rizhao Central Hospital
      • Contact: Maoxu Li
  • Shanxi
    • Taiyuan, Shanxi, China
      • Shanxi Candiovascular Hospital
      • Contact: Dong Kuai
  • Sichuan
    • Chengdu, Sichuan, China
      • School of medicine UESTC
      • Contact: Fuqiang Guo
    • Zigong, Sichuan, China
      • Zigong Third People's Hospital
      • Contact: Li Wang
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • The Second Affiliated Hospital of Zhejiang University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 .

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Patient Recruited; 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.	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Successful recanalization rate within three-times aspiration	Successful recanalization is defined as modified Thrombolysis In Cerebral Infarction scale(mTICI) 2b or 3 evaluated by Digital subtraction angiography (DSA).	Up to 90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Successful recanalization rate within three-times aspiration	Successful recanalization is defined as mTICI 2b or 3 evaluated by DSA.	Intraoperation
Successful recanalization rate beyond three-times aspiration	Successful recanalization is defined as mTICI 2b or 3 evaluated by DSA. Auxiliary device such as stent could be used.	Intraoperation
National Institute of Health stroke scale(NIHSS)	NIHSS score in 72 hours and 7 days(or the day when patients discharged, depends on which day is earlier) will be compared.	72 hours / 7 days
Rate of Modified Rankin Scale(mRS) score less than 3	The mRS score is assessed in 90 days follow-up.	90 days
Device delivery performance	Device delivery performance including transport and pullback performance, which is ranked excellent/good/normal/bad.	Intraoperation
The rate of symptomatic intracranial hemorrhage	National Institute of Health stroke scale(NIHSS) increased by at least 4 compared with the baseline.	72 hours
Death rate	Subjects who died from any cause would be counted.	Up to 90 days
The rate of AE	The definition of AE(Adverse Event) refers to ISO 14155	Up to 90 days
The rate of SAE	The definition of SAE (Serious Adverse Event) refers to ISO 14155	Up to 90 days
The rate of medical device deficiency	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.	Up to 90 days

Collaborators and Investigators

• Sponsor: Zhuhai Tonbridge Medical Tech. Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2022
• Primary Completion (Anticipated): June 1, 2023
• Study Completion (Anticipated): August 1, 2023

Study Registration Dates

• First Submitted: November 3, 2021
• First Submitted That Met QC Criteria: November 12, 2021
• First Posted (Actual): November 15, 2021

Study Record Updates

• Last Update Posted (Actual): June 28, 2022
• Last Update Submitted That Met QC Criteria: June 21, 2022
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Stroke; Aspiration; Catheter; Intracranial
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke
• Other Study ID Numbers: ZHTQ2021001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No