Efficacy and Safety of the Flow Diverter (Tonbridge) for Endovascular Treatment of Intracranial Aneurysms
1 other identifier
interventional
187
1 country
13
Brief Summary
The purpose of this study is to assess the efficacy and safety of the Flow Diverter (Tonbridge) for endovascular treatment of intracranial aneurysms.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2021
Typical duration for not_applicable
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 20, 2021
CompletedFirst Posted
Study publicly available on registry
March 16, 2021
CompletedStudy Start
First participant enrolled
August 12, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 22, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
September 22, 2023
CompletedSeptember 19, 2024
September 1, 2024
2.1 years
February 20, 2021
September 3, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Complete occlusion rate of aneurysms at 12 months
Complete occlusion is defined as no contrast agent in the aneurysm (Raymond-Roy class I) which is diagnosed by cerebrovascular DSA at 12 months post-procedure.
360±45 days post-procedure
Secondary Outcomes (10)
Immediate procedural success rate
intra-procedure
Complete occlusion rate of aneurysms at 6 months
180±30 days post-procedure
Subtotal occlusion rate
360±45 days post-procedure
Incidence of technical complications
intra-procedure
Incidence of stroke
within 360±45 days
- +5 more secondary outcomes
Study Arms (2)
Flow Diverter (Tonbridge)
EXPERIMENTALTreatment with Flow Diverter (Tonbridge)
Tubridge (MicroPort)
ACTIVE COMPARATORTreatment with Tubridge (MicroPort)
Interventions
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 introducer sheath. The stent and the delivery guide wire are pre-installed in the introducer sheath.
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.
Eligibility Criteria
You may qualify if:
- Age 18 to 80 years, any gender;
- Unruptured intracranial aneurysms locate in the internal carotid artery (ICA) or vertebral artery (VA) with a neck ≥ 4 mm and a maximal diameter ≥ 10 mm, which diagnosed by DSA;
- The target aneurysm with a parent vessel diameter of 2.0-6.5 mm;
- Subject or guardian is able to understand the purpose of study, shows sufficient compliance with the study protocol and provides a signed informed consent form.
You may not qualify if:
- Diagnosed as multiple aneurysms which cannot be covered by a single stent or with cerebrovascular malformations;
- Subarachnoid hemorrhage of the target aneurysm within 30 days pre-procedure;
- Modified Rankin Scale (mRS) score \> 2 in pre-procedure;
- Platelet (PLT) \< 60×10\^9/L or known platelet dysfunction or International Normalized Ratio (INR) \> 1.5;
- Heart, lung, liver and renal failure or other severe diseases (such as brain tumor, systemic infection, disseminated intravascular coagulation, myocardial infarction within 12 months before enrollment, history of severe psychosis);
- The lesion which is not appropriate for flow diverter delivery and deployment judged by investigators (severe stenosis of parent artery, severe tortuosity of parent artery, stent failing to reach the lesion, etc.);
- Major surgery within 30 days before enrollment, or intending to receive surgery within 180 days after enrollment;
- Allergic history of anesthetics and contrast agents, or contraindication for dual antiplatelet or/and anticoagulant therapy;
- Allergic History of metals such as nickel-titanium alloy;
- Life expectancy \< 12 months;
- Pregnant or breastfeeding women;
- Subject has participated in other drug or medical device clinical trials within 1 month before signing informed consent;
- Other conditions judged by the investigators as unsuitable for enrollment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
The First Affiliated Hospital of USTC
Hefei, Anhui, China
Nanfang Hospital Southern Medical University
Guangzhou, Guangdong, China
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, China
Nanyang Central Hospital
Nanyang, Henan, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Yichang Central People's Hospital
Yichang, Hubei, China
Hunan Provincial People's Hospital
Changsha, Hunan, China
Jiangsu Province Hospital
Nanjing, Jiangsu, China
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Zhejiang Hospital
Hangzhou, Zhejiang, China
Changhai Hospital of Shanghai
Shanghai, China
Huashan Hospital Fudan University
Shanghai, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jianmin Liu
Changhai Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 20, 2021
First Posted
March 16, 2021
Study Start
August 12, 2021
Primary Completion
September 22, 2023
Study Completion
September 22, 2023
Last Updated
September 19, 2024
Record last verified: 2024-09
Data Sharing
- IPD Sharing
- Will not share