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

Sponsor
Zhuhai Tonbridge Medical Tech. Co., Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT03550638
Collaborator
(none)
256
Enrollment
12
Locations
2
Arms
27.2
Actual Duration (Months)
21.3
Patients Per Site
0.8
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Coil system(Ton-bridgeMT)
  • Device: Axium Detachable Coil(Medtronic)
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
256 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Efficacy and Safety Study on Endovascular Embolization of Intracranial Aneurysms With Coil System(Ton-bridgeMT)
Actual Study Start Date :
May 28, 2018
Actual Primary Completion Date :
Jan 3, 2020
Actual Study Completion Date :
Sep 2, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: group A

Coil system(Ton-bridgeMT)

Device: Coil system(Ton-bridgeMT)
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.
Active Comparator: group B

Axium Detachable Coil(Medtronic)

Device: Axium Detachable Coil(Medtronic)
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.

Outcome Measures

Primary Outcome Measures

  1. success rate of occlusion [180 day]

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

Secondary Outcome Measures

  1. success rate of occlusion [intraoperation]

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

  2. Recurrence rate [180 day]

    2. Number of patients with recurrent aneurysms/ number of overall patients*100%

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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 .

Contacts and Locations

Locations

Site City State Country Postal Code
1 Zhongshan People's Hospital Zhongshan Guangdong China
2 Affiliated Hospital of Guizhou Medical University Guiyang Guizhou China
3 Nanjing Brain Hospital Nanjing Jiangsu China
4 Jiangsu Province Hospital Nanjin Jiangsu China
5 The first hospital of Jilin University Changchun Jilin China
6 First Affiliated Hospital of China Medical University Shenyang Liaoning China
7 Shengjing Hospital affiliated to China Medical University Shenyang Liaoning China
8 Yantai Yuhuangding Hospital Yantai Shandong China
9 Changhai Hospital of Shanghai Shanghai Shanghai China
10 Tangdu Hospital of The Fourth Military Medical University Xi'an Shanxi China
11 The Second Affiliated hospital of Zhejiang University School of Medicine Hanzhou China
12 The First Affiliated Hospital of Zhengzhou University Zhengzhou China

Sponsors and Collaborators

  • Zhuhai Tonbridge Medical Tech. Co., Ltd.

Investigators

  • Principal Investigator: Jianmin Liu, Changhai Hospital of Shangha

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Zhuhai Tonbridge Medical Tech. Co., Ltd.
ClinicalTrials.gov Identifier:
NCT03550638
Other Study ID Numbers:
  • ZHTQ2017001
First Posted:
Jun 8, 2018
Last Update Posted:
Apr 8, 2021
Last Verified:
Apr 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Intracranial Aneurysm
Aneurysm

Study Results

No Results Posted as of Apr 8, 2021