Clinical trial NCT03550638: 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
Overall status: COMPLETED
Phase: NA
Conditions: Intracranial Aneurysms
Lead sponsor: Ton-Bridge Medical Tech. Co., Ltd
Sponsor class: INDUSTRY
First posted: 2018-06-08
Enrollment: 256
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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 .

Primary outcomes:
measure: success rate of occlusion
timeFrame: 180 day
Secondary outcomes:
measure: success rate of occlusion
timeFrame: intraoperation
measure: Recurrence rate
timeFrame: 180 day
Other outcomes:
Locations:
city: Zhongshan
country: China
facility: Zhongshan People's Hospital
state: Guangdong
city: Guiyang
country: China
facility: Affiliated Hospital of Guizhou Medical University
state: Guizhou
city: Nanjing
country: China
facility: Nanjing Brain Hospital
state: Jiangsu
city: Nanjin
country: China
facility: Jiangsu Province Hospital
state: Jiangsu
city: Changchun
country: China
facility: The first hospital of Jilin University
state: Jilin
city: Shenyang
country: China
facility: First Affiliated Hospital of China Medical University
state: Liaoning
city: Shenyang
country: China
facility: Shengjing Hospital affiliated to China Medical University
state: Liaoning
city: Yantai
country: China
facility: Yantai Yuhuangding Hospital
state: Shandong
city: Shanghai
country: China
facility: Changhai Hospital of Shanghai
state: Shanghai
city: Xi'an
country: China
facility: Tangdu Hospital of The Fourth Military Medical University
state: Shanxi
city: Hanzhou
country: China
facility: The Second Affiliated hospital of Zhejiang University School of Medicine
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
Study officials:
affiliation: Changhai Hospital of Shangha
name: Jianmin Liu
role: PRINCIPAL_INVESTIGATOR
References: