Efficacy and Safety of the Self-expanding Intracranial Stent (Tonbridge) for Endovascular Treatment of Intracranial Aneurysms
- Conditions
- Intracranial Aneurysm
- Interventions
- Device: LVIS and LVIS Jr. (MicroVention)Device: Self-expanding Intracranial Stent (Tonbridge)
- Registration Number
- NCT05755516
- Lead Sponsor
- Zhuhai Tonbridge Medical Tech. Co., Ltd.
- 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).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 204
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description control group LVIS and LVIS Jr. (MicroVention) LVIS and LVIS Jr. (MicroVention) experimental group Self-expanding Intracranial Stent (Tonbridge) Self-expanding Intracranial Stent (Tonbridge)
- Primary Outcome Measures
Name Time Method Successful occlusion rate of aneurysms at 6 months 6 months±30 days post-procedure Successful occlusion is defined as complete occlusion or neck remnant (Raymond-Roy class I or Ⅱ), which is diagnosed by cerebrovascular DSA at 6 months post-procedure.
- Secondary Outcome Measures
Name Time Method Incidence of serious adverse events 180±30 days, 360±30 days post-procedure "Incidence of serious adverse events" is the proportion of subjects with serious adverse events using the investigational device or the comparator.
Retreatment rate 180±30 days, 360±30 days post-procedure Retreatment is defined as during the study period any additional treatment of the target aneurysm after the original procedure.
Incidence of parent artery occlusion in target area 180±30 days, 360±30 days post-procedure Parent artery occlusion in target area is diagnosed by postoperative cerebrovascular DSA at 6 months, CTA or MRA at 12 months.
Incidence of stroke 30±7 days, 360±30 days post-procedure Stroke includes hemorrhagic stroke and symptomatic ischemic stroke.
Device success rate intra-procedure Device success is that the stent is delivered to the target vessel successfully and covers the aneurysm neck effectively without stent migration or misplacement, etc. Device success is diagnosed by intraoperative cerebrovascular DSA.
All-cause mortality 30±7 days, 360±30 days post-procedure "All-cause mortality" is the proportion of subjects who die due to any cause.
Immediate successful occlusion rate of aneurysms intra-procedure Successful occlusion is defined as complete occlusion or neck remnant (Raymond-Roy class I or Ⅱ), which is diagnosed by intraoperative cerebrovascular DSA.
Incidence of adverse events 180±30 days, 360±30 days post-procedure "Incidence of adverse events" is the proportion of subjects with adverse events using the investigational device or the comparator.
Recurrence rate of aneurysms at 6 months 6 months±30 days post-procedure Recurrence is defined as increased contrast agent filling into the aneurysm sac at post-operative review compared to immediate post-procedure.
Operation satisfaction rate intra-procedure The 5-point Likert scale is used to evaluate the operation satisfaction from three aspects: push performance, retracting performance and release performance. "Operation satisfaction rate" is defined as the proportion of investigational devices or comparators with Likert score≥12 points.
Incidence of parent artery stenosis (>50%) in target area 180±30 days, 360±30 days post-procedure Parent artery stenosis in target area is defined as stenosis degree \>50%, which is diagnosed by postoperative cerebrovascular DSA at 6 months, CTA or MRA at 12 months.
Incidence of device deficiency intra-procedure, 180±30 days post-procedure Device deficiency is the unreasonable risk that may endanger human health and life safety in the normal use of medical devices during clinical trials, such as labeling errors, quality problems and malfunctions.
Trial Locations
- Locations (14)
The First Affiliated Hospital of Wannan Medical College
🇨🇳Wuhu, Anhui, China
Guangdong Provincial People's Hospital
🇨🇳Guangzhou, Guangdong, China
Zhujiang Hospital of Southern Medical University
🇨🇳Guangzhou, Guangdong, China
Zhuhai People's Hospital
🇨🇳Zhuhai, Guangdong, China
Tongji Hospital Tongji Medical College of HUST
🇨🇳Wuhan, Hubei, China
Xiangya Hospital of Central South University
🇨🇳Changsha, Hunan, China
General Hospital of Eastern Theater Command
🇨🇳Nanjing, Jiangsu, China
General Hospital of Northern Theater Command
🇨🇳Shenyang, Liaoning, China
Qilu Hospital of Shandong University
🇨🇳Jinan, Shandong, China
First Hospital of Shanxi Medical University
🇨🇳Taiyuan, Shanxi, China
Sichuan Academy of Medical Sciences·Sichuan Provincial People's Hospital
🇨🇳Chengdu, Sichuan, China
The First Affiliated Hospital Zhejiang University School of Medicine
🇨🇳Hangzhou, Zhejiang, China
The First Affiliated Hospital of Chongqing Medical University
🇨🇳Chongqing, China
Changhai Hospital of Shanghai
🇨🇳Shanghai, China