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

Intracranial Aneurysms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03550638
• Other study ID #: ZHTQ2017001
• Status: Completed
• Phase: N/A
• Start date: May 28, 2018
• Est. completion date: September 2, 2020

Study information

• Verified date: April 2021
• Source: Zhuhai Tonbridge Medical Tech. Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 256
• Est. completion date: September 2, 2020
• Est. primary completion date: January 3, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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 .

Related Conditions & MeSH terms

• Aneurysm
• Intracranial Aneurysm
• Intracranial Aneurysms

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	The first hospital of Jilin University	Changchun	Jilin
China	Affiliated Hospital of Guizhou Medical University	Guiyang	Guizhou
China	The Second Affiliated hospital of Zhejiang University School of Medicine	Hanzhou
China	Jiangsu Province Hospital	Nanjin	Jiangsu
China	Nanjing Brain Hospital	Nanjing	Jiangsu
China	Changhai Hospital of Shanghai	Shanghai	Shanghai
China	First Affiliated Hospital of China Medical University	Shenyang	Liaoning
China	Shengjing Hospital affiliated to China Medical University	Shenyang	Liaoning
China	Tangdu Hospital of The Fourth Military Medical University	Xi'an	Shanxi
China	Yantai Yuhuangding Hospital	Yantai	Shandong
China	The First Affiliated Hospital of Zhengzhou University	Zhengzhou
China	Zhongshan People's Hospital	Zhongshan	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Zhuhai Tonbridge Medical Tech. Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	success rate of occlusion	Number of aneurysms(Raymond ? and ?)/number of overall aneurysms*100%	180 day
Secondary	success rate of occlusion	Number of aneurysms(Raymond ? and ?)/number of overall aneurysms*100%	intraoperation
Secondary	Recurrence rate	2. Number of patients with recurrent aneurysms/ number of overall patients*100%	180 day