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

The Efficacy and Safety Study on Endovascular Embolization of Intracranial Aneurysms With Coil System(Ton-bridgeMT)

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.

Study Overview

• Status: Completed
• Conditions: Intracranial Aneurysms
• Intervention / Treatment: Device: Coil system(Ton-bridgeMT); Device: Axium Detachable Coil(Medtronic)

• Study Type: Interventional
• Enrollment (Actual): 256
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hanzhou, China
    • The Second Affiliated hospital of Zhejiang University school of medicine
  • Zhengzhou, China
    • The First Affiliated Hospital of Zhengzhou University
  • Guangdong
    • Zhongshan, Guangdong, China
      • Zhongshan People's Hospital
  • Guizhou
    • Guiyang, Guizhou, China
      • Affiliated Hospital of Guizhou Medical University
  • Jiangsu
    • Nanjin, Jiangsu, China
      • Jiangsu Province Hospital
    • Nanjing, Jiangsu, China
      • Nanjing Brain Hospital
  • Jilin
    • Changchun, Jilin, China
      • The First Hospital of Jilin University
  • Liaoning
    • Shenyang, Liaoning, China
      • Shengjing Hospital Affiliated to China Medical University
    • Shenyang, Liaoning, China
      • First Affiliated Hospital of China Medical University
  • Shandong
    • Yantai, Shandong, China
      • Yantai Yuhuangding Hospital
  • Shanghai
    • Shanghai, Shanghai, China
      • Changhai Hospital of Shanghai
  • Shanxi
    • Xi'an, Shanxi, China
      • Tangdu hospital of the Fourth Military Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 .

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
success rate of occlusion	Number of aneurysms(Raymond Ⅰ and Ⅱ)/number of overall aneurysms*100%	180 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
success rate of occlusion	Number of aneurysms(Raymond Ⅰ and Ⅱ)/number of overall aneurysms*100%	intraoperation
Recurrence rate	2. Number of patients with recurrent aneurysms/ number of overall patients*100%	180 day

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 28, 2018
• Primary Completion (ACTUAL): January 3, 2020
• Study Completion (ACTUAL): September 2, 2020

Study Registration Dates

• First Submitted: May 28, 2018
• First Submitted That Met QC Criteria: May 28, 2018
• First Posted (ACTUAL): June 8, 2018

Study Record Updates

• Last Update Posted (ACTUAL): April 8, 2021
• Last Update Submitted That Met QC Criteria: April 7, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Arterial Diseases; Aneurysm; Intracranial Aneurysm
• Other Study ID Numbers: ZHTQ2017001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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