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

Primary Purpose

Acute Ischemic Stroke

Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Thrombus Aspiration Catheter(Ton-bridgeMT)
Sponsored by
Zhuhai Tonbridge Medical Tech. Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Ischemic Stroke focused on measuring Stroke, Aspiration, Catheter, Intracranial

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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 .

Sites / Locations

  • The First Affiliated Hospital of USTC
  • Zhuhai people's hospital
  • The Second Nanning People's hospital
  • Cangzhou central hospital
  • Hunan Provincial People's Hospital
  • Ganzhou Municipal Hospital
  • Central Hospital Affiliated to Shangdong First Medical University
  • First People's Hospital of Jinan
  • The Second People's Hospital of Liaocheng
  • Rizhao central Hospital
  • Shanxi Candiovascular hospital
  • School of medicine UESTC
  • Zigong Third People's Hospital
  • The Second Affiliated Hospital of Zhejiang University School of Medicine
  • Xuanwu hospital Capital Medical University

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Patient Recruited

Arm 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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Successful recanalization rate within three-times aspiration
Successful recanalization is defined as mTICI 2b or 3 evaluated by DSA.
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.
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.
Rate of Modified Rankin Scale(mRS) score less than 3
The mRS score is assessed in 90 days follow-up.
Device delivery performance
Device delivery performance including transport and pullback performance, which is ranked excellent/good/normal/bad.
The rate of symptomatic intracranial hemorrhage
National Institute of Health stroke scale(NIHSS) increased by at least 4 compared with the baseline.
Death rate
Subjects who died from any cause would be counted.
The rate of AE
The definition of AE(Adverse Event) refers to ISO 14155
The rate of SAE
The definition of SAE (Serious Adverse Event) refers to ISO 14155
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.

Full Information

First Posted
November 3, 2021
Last Updated
June 21, 2022
Sponsor
Zhuhai Tonbridge Medical Tech. Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05119647
Brief Title
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

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 2022 (Anticipated)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
August 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zhuhai Tonbridge Medical Tech. Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Ischemic Stroke
Keywords
Stroke, Aspiration, Catheter, Intracranial

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
155 (Anticipated)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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 .
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Peiyi Li
Phone
13840536851
Email
py.li@ton-bridge.com
First Name & Middle Initial & Last Name or Official Title & Degree
Dingrong Pan
Phone
18868106641
Email
dr.pan@ton-bridge.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liqun Jiao
Organizational Affiliation
Xuanwu Hospital, Beijing
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Affiliated Hospital of USTC
City
Hefei
State/Province
Anhui
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wei Hu
Facility Name
Zhuhai people's hospital
City
Zhuhai
State/Province
Guangdong
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ligong Lu
Facility Name
The Second Nanning People's hospital
City
Nanning
State/Province
Guangxi
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tong Li
Facility Name
Cangzhou central hospital
City
Cangzhou
State/Province
Hebei
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yongchang Liu
Facility Name
Hunan Provincial People's Hospital
City
Changsha
State/Province
Hunan
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hua Xiang
Facility Name
Ganzhou Municipal Hospital
City
Ganzhou
State/Province
Jiangxi
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hanwen Liu
Facility Name
Central Hospital Affiliated to Shangdong First Medical University
City
Jinan
State/Province
Shandong
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yanxin Zhao
Facility Name
First People's Hospital of Jinan
City
Jinan
State/Province
Shandong
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianfeng Chu
Facility Name
The Second People's Hospital of Liaocheng
City
Liaocheng
State/Province
Shandong
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xinqiang Wang
Facility Name
Rizhao central Hospital
City
Rizhao
State/Province
Shandong
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maoxu Li
Facility Name
Shanxi Candiovascular hospital
City
Taiyuan
State/Province
Shanxi
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dong Kuai
Facility Name
School of medicine UESTC
City
Chengdu
State/Province
Sichuan
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fuqiang Guo
Facility Name
Zigong Third People's Hospital
City
Zigong
State/Province
Sichuan
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Li Wang
Facility Name
The Second Affiliated Hospital of Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jing Xu
Facility Name
Xuanwu hospital Capital Medical University
City
Beijing
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liqun Jiao

12. IPD Sharing Statement

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

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