Clinical trial NCT05755516: Efficacy and Safety of the Self-expanding Intracranial Stent (Tonbridge) for Endovascular Treatment of Intracranial Aneurysms
Official title: Efficacy and Safety of the Self-expanding Intracranial Stent (Tonbridge) for Endovascular Treatment of Intracranial Aneurysms: a Prospective, Multi-center, Randomized, Open, Parallel Positive Controlled, Non-inferiority Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Intracranial Aneurysm
Lead sponsor: Ton-Bridge Medical Tech. Co., Ltd
Sponsor class: INDUSTRY
First posted: 2023-03-06
Enrollment: 204
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 Self-expanding Intracranial Stent (Tonbridge), by comparing the data obtained from Self-expanding Intracranial Stent (Zhuhai Tonbridge Medical Tech. Co., Ltd.) and LVIS/LVIS Jr. (MicroVention Europe SARL) for endovascular treatment of intracranial aneurysms.

Detailed description: This is a prospective, multi-center, randomized, open, parallel positive controlled, non-inferiority trial. This clinical trial is conducted at more than 2 centers in China, and patients who intend to be treated with stent-assisted coiling for intracranial aneurysms are enrolled. Eligible patients are randomized into experimental group using Self-expanding Intracranial Stent (Tonbridge) or control group using LVIS and LVIS Jr. (MicroVention) in a 1:1 ratio. The purpose of this study is to evaluate the effectiveness and safety of the Self-expanding Intracranial Stent (Tonbridge).

Eligibility criteria: Inclusion Criteria:

* Age 18 to 80 years, any gender;
* Diagnosed as intracranial aneurysm and the subject is assessed as suitable for stent-assisted coiling;
* 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:

* Aneurysm rupture within 30 days before enrollment;
* Diagnosed as blood blister-like aneurysm, pseudoaneurysm, infected aneurysm, or aneurysm related to arteriovenous malformations;
* Conditions that are not appropriate for stent delivery and deployment judged by investigators (severe stenosis of parent artery, severe tortuosity of parent artery, stent failing to reach the lesion, stent in the target lesion of parent artery, etc.);
* Modified Rankin Scale (mRS) score ≥3;
* Heart, lung, liver and renal failure or other severe diseases (intracranial tumor, systemic infection, disseminated intravascular coagulation, myocardial infarction within 12 months before enrollment, history of severe psychosis, severe stenosis or occlusion of cerebral feeding artery, etc.);
* Major surgery within 30 days before enrollment；
* Known coagulation dysfunction or contraindication to anticoagulant and antiplatelet therapy;
* Known allergy to nickel-titanium alloy metal materials;
* 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: Successful occlusion rate of aneurysms at 6 months
timeFrame: 6 months±30 days post-procedure
Secondary outcomes:
measure: Device success rate
timeFrame: intra-procedure
measure: Immediate successful occlusion rate of aneurysms
timeFrame: intra-procedure
measure: Recurrence rate of aneurysms at 6 months
timeFrame: 6 months±30 days post-procedure
measure: Retreatment rate
timeFrame: 180±30 days, 360±30 days post-procedure
measure: Operation satisfaction rate
timeFrame: intra-procedure
measure: Incidence of parent artery stenosis (>50%) in target area
timeFrame: 180±30 days, 360±30 days post-procedure
measure: Incidence of parent artery occlusion in target area
timeFrame: 180±30 days, 360±30 days post-procedure
measure: Incidence of stroke
timeFrame: 30±7 days, 360±30 days post-procedure
measure: All-cause mortality
timeFrame: 30±7 days, 360±30 days post-procedure
measure: Incidence of adverse events
timeFrame: 180±30 days, 360±30 days post-procedure
measure: Incidence of serious adverse events
timeFrame: 180±30 days, 360±30 days post-procedure
measure: Incidence of device deficiency
timeFrame: intra-procedure, 180±30 days post-procedure
Other outcomes:
Locations:
city: Wuhu
country: China
facility: The First Affiliated Hospital of Wannan Medical College
state: Anhui
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Zhujiang Hospital of Southern Medical University
state: Guangdong
city: Zhuhai
country: China
facility: Zhuhai People's Hospital
state: Guangdong
city: Wuhan
country: China
facility: Tongji Hospital Tongji Medical College of HUST
state: Hubei
city: Changsha
country: China
facility: Xiangya Hospital of Central South University
state: Hunan
city: Nanjing
country: China
facility: General Hospital of Eastern Theater Command
state: Jiangsu
city: Shenyang
country: China
facility: General Hospital of Northern Theater Command
state: Liaoning
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
city: Taiyuan
country: China
facility: First Hospital of Shanxi Medical University
state: Shanxi
city: Chengdu
country: China
facility: Sichuan Academy of Medical Sciences·Sichuan Provincial People's Hospital
state: Sichuan
city: Hangzhou
country: China
facility: The First Affiliated Hospital Zhejiang University School of Medicine
state: Zhejiang
city: Chongqing
country: China
facility: The First Affiliated Hospital of Chongqing Medical University
city: Shanghai
country: China
facility: Changhai Hospital of Shanghai
Study officials:
affiliation: Changhai Hospital
name: Jianmin Liu
role: PRINCIPAL_INVESTIGATOR
affiliation: Southern Medical University, China
name: Chuanzhi Duan
role: PRINCIPAL_INVESTIGATOR
References: