Efficacy and Safety of the Self-expanding Intracranial Stent (Tonbridge) for Endovascular Treatment of Intracranial Aneurysms

Study Overview
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Brief Summary
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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
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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).

Official Title
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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

Conditions
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Intracranial Aneurysm

Intervention / Treatment
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* Device: Self-expanding Intracranial Stent (Tonbridge)
* Device: LVIS and LVIS Jr. (MicroVention)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: experimental group<br>Self-expanding Intracranial Stent (Tonbridge) | Device: Self-expanding Intracranial Stent (Tonbridge)<br>* Stent assisted coiling with Self-expanding Intracranial Stent (Tonbridge).<br>|
| Active Comparator: control group<br>LVIS and LVIS Jr. (MicroVention) | Device: LVIS and LVIS Jr. (MicroVention)<br>* Stent assisted coiling with LVIS and LVIS Jr. (MicroVention).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful occlusion rate of aneurysms at 6 months | 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. | 6 months±30 days post-procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device success rate | 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. | intra-procedure | 
| Immediate successful occlusion rate of aneurysms | Successful occlusion is defined as complete occlusion or neck remnant (Raymond-Roy class I or Ⅱ), which is diagnosed by intraoperative cerebrovascular DSA. | intra-procedure | 
| Recurrence rate of aneurysms at 6 months | Recurrence is defined as increased contrast agent filling into the aneurysm sac at post-operative review compared to immediate post-procedure. | 6 months±30 days post-procedure | 
| Retreatment rate | Retreatment is defined as during the study period any additional treatment of the target aneurysm after the original procedure. | 180±30 days, 360±30 days post-procedure | 
| Operation satisfaction rate | 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. | intra-procedure | 
| Incidence of parent artery stenosis (>50%) in target area | 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. | 180±30 days, 360±30 days post-procedure | 
| Incidence of parent artery occlusion in target area | Parent artery occlusion in target area is diagnosed by postoperative cerebrovascular DSA at 6 months, CTA or MRA at 12 months. | 180±30 days, 360±30 days post-procedure | 
| Incidence of stroke | Stroke includes hemorrhagic stroke and symptomatic ischemic stroke. | 30±7 days, 360±30 days post-procedure | 
| All-cause mortality | All-cause mortality is the proportion of subjects who die due to any cause. | 30±7 days, 360±30 days post-procedure | 
| Incidence of adverse events | Incidence of adverse events is the proportion of subjects with adverse events using the investigational device or the comparator. | 180±30 days, 360±30 days post-procedure | 
| Incidence of serious adverse events | Incidence of serious adverse events is the proportion of subjects with serious adverse events using the investigational device or the comparator. | 180±30 days, 360±30 days post-procedure | 
| Incidence of device deficiency | 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. | intra-procedure, 180±30 days post-procedure |