Intracranial Aneurysm
Conditions
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).
Interventions
DEVICESelf-expanding Intracranial Stent (Tonbridge)
Stent assisted coiling with Self-expanding Intracranial Stent (Tonbridge).
DEVICELVIS and LVIS Jr. (MicroVention)
Stent assisted coiling with LVIS and LVIS Jr. (MicroVention).
Sponsors
Ton-Bridge Medical Tech. Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| Incidence of stroke | 30±7 days, 360±30 days post-procedure | Stroke includes hemorrhagic stroke and symptomatic ischemic stroke. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
Countries
China
Outcome results
None listed