Clinical trial NCT04799964: Efficacy and Safety of the Flow Diverter (Tonbridge) for Endovascular Treatment of Intracranial Aneurysms
Official title: Efficacy and Safety of the Flow Diverter (Tonbridge) for Endovascular Treatment of Intracranial Aneurysms: a Prospective, Multi-center, Randomized, Open, Positive-controlled, Non-inferiority Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intracranial Aneurysm
Lead sponsor: Ton-Bridge Medical Tech. Co., Ltd
Sponsor class: INDUSTRY
First posted: 2021-03-16
Enrollment: 187
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 purpose of this study is to assess the efficacy and safety of the Flow Diverter (Tonbridge) for endovascular treatment of intracranial aneurysms.

Detailed description: This is a prospective, multi-center, randomized, open, positive-controlled, non-inferiority trial. This clinical trial is conducted at more than 5 centers in China. Eligible patients are randomized into experimental group using Flow Diverter (Tonbridge) or control group using Tubridge (MicroPort) in a 1:1 ratio. The primary objective of this study is to verify the complete occlusion rate of aneurysms at 12 months of Flow Diverter (Tonbridge) is non-inferior to Tubridge, for treatment of intracranial aneurysms, and evaluate the effectiveness and safety of the Flow Diverter (Tonbridge).

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Complete occlusion rate of aneurysms at 12 months
timeFrame: 360±45 days post-procedure
Secondary outcomes:
measure: Immediate procedural success rate
timeFrame: intra-procedure
measure: Complete occlusion rate of aneurysms at 6 months
timeFrame: 180±30 days post-procedure
measure: Subtotal occlusion rate
timeFrame: 360±45 days post-procedure
measure: Incidence of technical complications
timeFrame: intra-procedure
measure: Incidence of stroke
timeFrame: within 360±45 days
measure: Incidence of parent artery stenosis ( > 50%) in target area at 360 days and incidence of parent artery occlusion in target area at 360 days
timeFrame: 360±45 days post-procedure
measure: Incidence of adverse events and incidence of serious adverse events
timeFrame: within 360±45 days
measure: Mortality rate
timeFrame: within 360±45 days
measure: Operation satisfaction rate
timeFrame: intra-procedure
measure: Incidence of device deficiency
timeFrame: within 360±45 days
Other outcomes:
Locations:
city: Hefei
country: China
facility: The First Affiliated Hospital of USTC
state: Anhui
city: Guangzhou
country: China
facility: Nanfang Hospital Southern Medical University
state: Guangdong
city: Guangzhou
country: China
facility: Zhujiang Hospital of Southern Medical University
state: Guangdong
city: Nanyang
country: China
facility: Nanyang Central Hospital
state: Henan
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
state: Henan
city: Yichang
country: China
facility: Yichang Central People's Hospital
state: Hubei
city: Changsha
country: China
facility: Hunan Provincial People's Hospital
state: Hunan
city: Nanjing
country: China
facility: Jiangsu Province Hospital
state: Jiangsu
city: Nanchang
country: China
facility: The Second Affiliated Hospital of Nanchang University
state: Jiangxi
city: Hangzhou
country: China
facility: The Second Affiliated Hospital Zhejiang University School of Medicine
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang Hospital
state: Zhejiang
city: Shanghai
country: China
facility: Changhai Hospital of Shanghai
city: Shanghai
country: China
facility: Huashan Hospital Fudan University
Study officials:
affiliation: Changhai Hospital
name: Jianmin Liu
role: PRINCIPAL_INVESTIGATOR
References: