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.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
204
Stent assisted coiling with Self-expanding Intracranial Stent (Tonbridge).
Stent assisted coiling with LVIS and LVIS Jr. (MicroVention).
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
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.
Time frame: 6 months±30 days post-procedure
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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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
...and 4 more locations
Time frame: 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.
Time frame: 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.
Time frame: 180±30 days, 360±30 days post-procedure
Incidence of stroke
Stroke includes hemorrhagic stroke and symptomatic ischemic stroke.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: intra-procedure, 180±30 days post-procedure