Flow Diverter(Ton-bridgeMT) For Treating Intracranial Aneurysms

  • STATUS
    Recruiting
  • days left to enroll
    35
  • participants needed
    186
  • sponsor
    Zhuhai Tonbridge Medical Tech. Co., Ltd.
Updated on 7 July 2022

Summary

This is a prospective, multi-center, randomized, open, parallel positive control, non-inferiority trail. The purpose of this study is assess the effectiveness and safety of the flow diverter(Ton-bridgeMT) by comparing with the data obtained by Tubridge for the endovascular treatment of intracranial aneurysms.

Description

The Flow Diverter is an intracranial implant designed to be placed in a parent artery so as to divert blood flow away from an aneurysm. This clinical trial is carried out in 14 research centers. The subjects are randomly divided into the experimental group using flow diverter(Ton-bridgeMT) and the control group using Tubridge at a ratio of 1:1.

Details
Condition Intracranial Aneurysm
Treatment Flow diverter(Ton-bridgeMT, China), Tubridge(Microport, China)
Clinical Study IdentifierNCT04799964
SponsorZhuhai Tonbridge Medical Tech. Co., Ltd.
Last Modified on7 July 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Age 18 to 80 years
Subject has unruptured aneurysms located in Vertebral artery(VA) or Internal Carotid Artery(ICA) diagnosed by DSA;
The neck width of the aneurysm ≥4 mm, the max diameter of the aneurysm body ≥10 mm
The diameter of the target vessel is 2.0 to 6.5mm
Subject or legal representative is able to understand the purpose of study, agrees to comply with protocol requirements and has provided written informed consent

Exclusion Criteria

Diagnosed as multiple aneurysms that can't be treated by single device or with arteriovenous malformation
Subject had a subarachnoid hemorrhage within 30 days prior to the enrollment date
Modified Rankin Scale(mRS) score >2
Platelet(PLT)<6010^9/L or International Normalized Ratio(INR)>1.5
Heart, lung, liver, kidney failure or other serious diseases (such as brain tumors, systemic infection, active disseminated intravascular coagulation, myocardial infarction within 12 months before enrollment, history of severe mental illness)
Lesions judged by researchers that are not suitable for stent delivery and deployment (such as severe stenosis of the tumor-bearing artery, too tortuous tumor-bearing artery, and the stent cannot reach the lesion, etc.)
Have undergone major surgery within 30 days before enrollment or plan to undergo surgery within 180 days after enrollment
History of allergies to antiplatelet drugs, anticoagulants, anesthetics, contrast agents
History of allergies to platinum and tungsten
Expected life <12 months
Female subjects who are pregnant or planning to become pregnant or lactate within the study period
Subject has participated in any other drug or medical device clinical trials in 1 month before signing informed consent
Other circumstances judged by researchers that are not suitable for enrollment
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