Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Flow Diverter(Ton-bridgeMT) For Treating Intracranial Aneurysms

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04799964
Recruitment Status : Recruiting
First Posted : March 16, 2021
Last Update Posted : December 17, 2021
Sponsor:
Information provided by (Responsible Party):
Zhuhai Tonbridge Medical Tech. Co., Ltd.

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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.

Condition or disease Intervention/treatment Phase
Intracranial Aneurysm Device: Flow diverter(Ton-bridgeMT, China) Device: Tubridge(Microport, China) Not Applicable

Detailed 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.
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 186 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Efficacy and Safety Study of Flow Diverter(Ton-bridgeMT) on Endovascular Embolization of Intracranial Aneurysms
Actual Study Start Date : September 7, 2021
Estimated Primary Completion Date : January 2023
Estimated Study Completion Date : January 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Group A
Flow diverter(Ton-bridgeMT, China)
 Device: Flow diverter(Ton-bridgeMT, China)
The device is a self-expanding vascular stent system, which consists of a stent and a delivery system. The stent is made of platinum core nickel-titanium alloy material. The delivery system is composed of a delivery guide wire and an introduction sheath. The stent and the delivery guide wire are pre-installed in the introduction sheath.
Active Comparator: Group B
Tubridge(Microport, China)
 Device: Tubridge(Microport, China)
Tubridge consists of a stent system and a microcatheter system. The stent system consists of a stent and a conveyor, the stent is self-expanding as well.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Complete occlusion rate of aneurysms [ Time Frame: 360±45 days ]
    The Raymond-Roy intracranial aneurysm occlusion classification was used to assess the rate of aneurysm occlusion at the time of primary endpoint assessment (12 months). Occlusion rates were reported as Class I: complete obliteration; Class II: residual neck; Class III: residual aneurysm.


Secondary Outcome Measures :
  1. Success rate of operation [ Time Frame: Intraoperation ]
    Successful operation represents that the positioning of the test stent is accurate and effectively covers the aneurysm neck after intraoperative DSA(Digital subtraction angiography) examination of the vessels.

  2. Complete occlusion rate of aneurysms [ Time Frame: 180±30days ]
    The Raymond-Roy intracranial aneurysm occlusion classification was used to assess the occlusion rate of aneurysms, class I means complete occlusion of the aneurysms.

  3. Subtotal occlusion rate [ Time Frame: 360±45 days ]
    Subtotal occlusion is defined as less than 10% of the contrast agent in the aneurysm.


Other Outcome Measures:
  1. The rate of stroke [ Time Frame: Up to 1 year ]
    Stroke includes symptomatic ischemic stroke and hemorrhagic stroke.

  2. The rate of the target vessel stenosis more that 50% and 100% [ Time Frame: 360±45 days ]
    The subjects receive DSA examination in 360 days at the 12 months follow-up.

  3. Procedure-related complication [ Time Frame: Intraoperation ]
    Procedure-related complications include but are not limited to: incomplete stent opening, stent displacement, stent entry into the tumor, stent thrombosis, operation injury.

  4. The rate of AE/SAE [ Time Frame: Up to 1 year ]
    The definition of AE(Adverse Event) / SAE (Serious Adverse Event) refers to ISO 14155

  5. Death rate [ Time Frame: Up to 1 year ]
    Subjects who died from any cause would be counted.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)<60*10^9/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 .
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04799964


Contacts
Layout table for location contacts
Contact: Danqing Shen 15858207851 dq.shen@ton-bridge.com
Contact: Dingrong Pan 18868106641 dr.pan@ton-bridge.com

Locations
Layout table for location information
China, Anhui
The First Affiliated Hospital of USTC Recruiting
Hefei, Anhui, China
Contact: Ge Gao         
China, Guangdong
Nanfang Hospital of Southern Medical University Recruiting
Guangzhou, Guangdong, China
Contact: Wenfeng Feng         
Zhujiang Hospital of Southern Medical University Recruiting
Guangzhou, Guangdong, China
Contact: Chuanzhi Duan         
Zhuhai people's hospital Recruiting
Zhuhai, Guangdong, China
Contact: Guangsen Cheng         
China, Guangxi
The people's hospital of Guangxi Zhuang Autonomous Region Recruiting
Nanning, Guangxi, China
Contact: Shengyong Lan         
China, Henan
Henan provincial People's Hostpital Recruiting
Zhengzhou, Henan, China
Contact: Tianxiao Li         
The First Affiliated Hospital of Zhengzhou University Recruiting
Zhengzhou, Henan, China
Contact: Sheng Guan         
China, Hubei
Zhongnan Hospital of Wuhan University Recruiting
Wuhan, Hubei, China
Contact: Wenyuan Zhao         
China, Hunan
Xiangya Hospital Central South University Recruiting
Changsha, Hunan, China
Contact: Fenghua Chen         
China, Jiangsu
Jiangsu Province hospital Recruiting
Nanjing, Jiangsu, China
Contact: Hua Lu         
China, Jiangxi
The Second Affiliated Hospital of Nanchang University Recruiting
Nanchang, Jiangxi, China
Contact: Guohua Mao         
China, Shanghai
Changhai Hospital of Shanghai Recruiting
Shanghai, Shanghai, China
Contact: Jianmin Liu    13901780638      
Huashan Hospital Affiliated to Fudan University Recruiting
Shanghai, Shanghai, China
Contact: Yuxiang Gu         
China, Zhejiang
Zhejiang hospital Recruiting
Hangzhou, Zhejiang, China
Contact: Shu Wan         
Sponsors and Collaborators
Zhuhai Tonbridge Medical Tech. Co., Ltd.
Investigators
Layout table for investigator information
Principal Investigator: Jianmin Liu Changhai Hospital
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Zhuhai Tonbridge Medical Tech. Co., Ltd.
ClinicalTrials.gov Identifier: NCT04799964    
Other Study ID Numbers: ZHTQ2020001
First Posted: March 16, 2021    Key Record Dates
Last Update Posted: December 17, 2021
Last Verified: December 2021

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Intracranial Aneurysm
Aneurysm
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases
 Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases