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Coil System(Ton-bridgeMT) for Endovascular Embolization of Cranial Aneurysms

Primary Purpose

Intracranial Aneurysms

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Coil system(Ton-bridgeMT)
Axium Detachable Coil(Medtronic)
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 Intracranial Aneurysms

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 18-80 years.
  • Subject has a target intracranial aneurysm (IA) diagnosed by DSA, and intended to be embolised with coil system.
  • Subject or guardian is able to understand the purpose of study, agrees to comply with protocol requirements and has provided written informed consent.

Exclusion Criteria:

  • Subject is diagnosed as multiple aneurysms.
  • Subject is diagnosed as intracranial bulloid, fusiform, false, dissectimng, infective aneurysm or with arteriovenous malformation.
  • mRS score≥3.
  • Hunt and Hess classification≥4.
  • Subject has emergency ruptured aneurysms and needs assisting stent.
  • The target aneurysm has received endovascular embolization or surgical treatment.
  • The aneurysm carrier artery has severe stenosis.
  • PLT<60×109/L or INR>1.5.
  • Subject has nonfunction of important organs or other severe diseases.
  • Major surgery in the last 30 days, or intending to receive surgical treatment in 90 days after enrollment.
  • Subject is allergic to antiplatelet drugs, anticoagulants, anesthetics, contrast agents or any related contraindication.
  • History of allergies to platinum and tungsten.
  • Expected life <12 months.
  • Pregnant or lactating women.
  • Subject has participated in any other drug or medical device clinical trials in 1 month before writting informed consent .
  • Other circumstances judged by researchers are not suitable for enrollment .

Sites / Locations

  • Zhongshan People's Hospital
  • Affiliated Hospital of Guizhou Medical University
  • Nanjing Brain Hospital
  • Jiangsu Province Hospital
  • The first hospital of Jilin University
  • First Affiliated Hospital of China Medical University
  • Shengjing Hospital affiliated to China Medical University
  • Yantai Yuhuangding Hospital
  • Changhai Hospital of Shanghai
  • Tangdu Hospital of The Fourth Military Medical University
  • The Second Affiliated hospital of Zhejiang University School of Medicine
  • The First Affiliated Hospital of Zhengzhou University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

group A

group B

Arm Description

Coil system(Ton-bridgeMT)

Axium Detachable Coil(Medtronic)

Outcomes

Primary Outcome Measures

success rate of occlusion
Number of aneurysms(Raymond Ⅰ and Ⅱ)/number of overall aneurysms*100%

Secondary Outcome Measures

success rate of occlusion
Number of aneurysms(Raymond Ⅰ and Ⅱ)/number of overall aneurysms*100%
Recurrence rate
2. Number of patients with recurrent aneurysms/ number of overall patients*100%

Full Information

First Posted
May 28, 2018
Last Updated
April 7, 2021
Sponsor
Zhuhai Tonbridge Medical Tech. Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03550638
Brief Title
Coil System(Ton-bridgeMT) for Endovascular Embolization of Cranial Aneurysms
Official Title
The Efficacy and Safety Study on Endovascular Embolization of Intracranial Aneurysms With Coil System(Ton-bridgeMT)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
May 28, 2018 (Actual)
Primary Completion Date
January 3, 2020 (Actual)
Study Completion Date
September 2, 2020 (Actual)

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
The study is a prospective, multi-center, randomized, open, parallel positive control, non-inferiority trial. Patients are randomized 1:1 to either Coil System(Ton-bridgeMT) or Axium Detachable Coil(Medtronic). The purpose of this study is to assess the safety and effectiveness of the Coil System(Ton-bridgeMT) in the treatment of intracranial aneurysms.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intracranial Aneurysms

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
256 (Actual)

8. Arms, Groups, and Interventions

Arm Title
group A
Arm Type
Experimental
Arm Description
Coil system(Ton-bridgeMT)
Arm Title
group B
Arm Type
Active Comparator
Arm Description
Axium Detachable Coil(Medtronic)
Intervention Type
Device
Intervention Name(s)
Coil system(Ton-bridgeMT)
Intervention Description
1. It consists of a push system with a development mark, and a Detachable platinum-tungsten alloy coil which is connected to the push system. It can be used for embolization of intracranial aneurysms, and other neurovascular abnormalities, such as arteriovenous malformation and arteriovenous fistula.
Intervention Type
Device
Intervention Name(s)
Axium Detachable Coil(Medtronic)
Intervention Description
2. It is made up of a push system with a development mark, a platinum-tungsten alloy embolized coil connected to the push system and a manual release device for releasing the coil from the distal end of the push system. It is mainly used for embolization of intracranial aneurysms, and other neurovascular abnormalities, such as arteriovenous malformation and arteriovenous fistula.
Primary Outcome Measure Information:
Title
success rate of occlusion
Description
Number of aneurysms(Raymond Ⅰ and Ⅱ)/number of overall aneurysms*100%
Time Frame
180 day
Secondary Outcome Measure Information:
Title
success rate of occlusion
Description
Number of aneurysms(Raymond Ⅰ and Ⅱ)/number of overall aneurysms*100%
Time Frame
intraoperation
Title
Recurrence rate
Description
2. Number of patients with recurrent aneurysms/ number of overall patients*100%
Time Frame
180 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18-80 years. Subject has a target intracranial aneurysm (IA) diagnosed by DSA, and intended to be embolised with coil system. Subject or guardian is able to understand the purpose of study, agrees to comply with protocol requirements and has provided written informed consent. Exclusion Criteria: Subject is diagnosed as multiple aneurysms. Subject is diagnosed as intracranial bulloid, fusiform, false, dissectimng, infective aneurysm or with arteriovenous malformation. mRS score≥3. Hunt and Hess classification≥4. Subject has emergency ruptured aneurysms and needs assisting stent. The target aneurysm has received endovascular embolization or surgical treatment. The aneurysm carrier artery has severe stenosis. PLT<60×109/L or INR>1.5. Subject has nonfunction of important organs or other severe diseases. Major surgery in the last 30 days, or intending to receive surgical treatment in 90 days after enrollment. Subject is allergic to antiplatelet drugs, anticoagulants, anesthetics, contrast agents or any related contraindication. History of allergies to platinum and tungsten. Expected life <12 months. Pregnant or lactating women. Subject has participated in any other drug or medical device clinical trials in 1 month before writting informed consent . Other circumstances judged by researchers are not suitable for enrollment .
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jianmin Liu
Organizational Affiliation
Changhai Hospital of Shangha
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zhongshan People's Hospital
City
Zhongshan
State/Province
Guangdong
Country
China
Facility Name
Affiliated Hospital of Guizhou Medical University
City
Guiyang
State/Province
Guizhou
Country
China
Facility Name
Nanjing Brain Hospital
City
Nanjing
State/Province
Jiangsu
Country
China
Facility Name
Jiangsu Province Hospital
City
Nanjin
State/Province
Jiangsu
Country
China
Facility Name
The first hospital of Jilin University
City
Changchun
State/Province
Jilin
Country
China
Facility Name
First Affiliated Hospital of China Medical University
City
Shenyang
State/Province
Liaoning
Country
China
Facility Name
Shengjing Hospital affiliated to China Medical University
City
Shenyang
State/Province
Liaoning
Country
China
Facility Name
Yantai Yuhuangding Hospital
City
Yantai
State/Province
Shandong
Country
China
Facility Name
Changhai Hospital of Shanghai
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Tangdu Hospital of The Fourth Military Medical University
City
Xi'an
State/Province
Shanxi
Country
China
Facility Name
The Second Affiliated hospital of Zhejiang University School of Medicine
City
Hanzhou
Country
China
Facility Name
The First Affiliated Hospital of Zhengzhou University
City
Zhengzhou
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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Coil System(Ton-bridgeMT) for Endovascular Embolization of Cranial Aneurysms

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