The purpose of this study is to assess the effectiveness and safety of the Flow Diverter (Tonbridge) by collecting data from subjects who receive endovascular treatment of intracranial aneurysms.
This is a prospective, multi-center, single-arm clinical trial carried out in 7 research centers over China. In this study, enrolled patients are treated with the Flow Diverter (Tonbridge) for intracranial aneurysms. The objective of this study is to evaluate the effectiveness and safety of the Flow Diverter (Tonbridge) for treatment of intracranial aneurysms.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
142
The device is a self-expanding vascular stent system, which consists of a stent and a delivery system. The stent is made of platinum core nickel-titanium alloy material. The delivery system is composed of a delivery guide wire and an introducer sheath. The stent and the delivery guide wire are pre-installed in the introducer sheath.
The First Affiliated Hospital of Wannan Medical College
Wuhu, Anhui, China
Henan Provincial People's Hospital
Zhengzhou, Henan, China
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China
Zhejiang Hospital
Hangzhou, Zhejiang, China
Complete occlusion rate of aneurysms at 12 months
Complete occlusion is defined as no contrast agent in the aneurysm (Raymond-Roy class I) which is diagnosed by cerebrovascular DSA at 12 months post-procedure.
Time frame: 360±30 days post-procedure
Immediate procedural success rate
Intraoperative cerebrovascular DSA is performed to determine whether the investigational device positions exactly and covers the aneurysm neck effectively.
Time frame: intra-procedure
Complete occlusion rate of aneurysms at 6 months
Complete occlusion is defined as no contrast agent in the aneurysm (Raymond-Roy class I) which is diagnosed by MRA/CTA at 6 months post-procedure.
Time frame: 180±30 days post-procedure
Successful occlusion rate of aneurysms at 12 months
Successful occlusion is defined as Raymond-Roy class I or II, which is diagnosed by DSA at 12 months post-procedure.
Time frame: 360±30 days post-procedure
Incidence of new-onset stroke in the territory supplied by the treated artery or neurologic death at 12 months
New-onset stroke is defined as the occurrence of new stroke with an increase of ≥ 4 points in the subjects' NIHSS score from preoperative baseline. Neurologic death is defined as death due to neurologic reasons directly.
Time frame: 360±30 days post-procedure
Incidence of technical complications
Technical complications include but not limited to: stent incomplete opening, stent migration, stent herniation into the aneurysm sac, in-stent thrombosis, operation injury, etc.
Time frame: intra-procedure
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Xinqiao Hospital, Army Medical University
Chongqing, China
Changhai Hospital of Shanghai
Shanghai, China
Huashan Hospital Fudan University
Shanghai, China
Incidence of any stroke
Stroke includes hemorrhagic stroke and symptomatic ischemic stroke.
Time frame: 30±7 days, 360±30 days post-procedure
Incidence of parent artery stenosis ( > 50%)in target area at 12 months
Parent artery stenosis in target area is defined as stenosis degree \> 50%. Using postoperative cerebrovascular DSA at 12 months is performed to determine.
Time frame: 360±30 days post-procedure
Incidence of parent artery occlusion in target area at 12 months
Postoperative cerebrovascular DSA at 12 months is performed to determine whether parent artery in target area is occluded.
Time frame: 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.
Time frame: pre-procedure, intra-procedure, within 24 hours, 30±7 days, 90±14 days, 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.
Time frame: pre-procedure, intra-procedure, within 24 hours, 30±7 days, 90±14 days, 180±30 days, 360±30 days post-procedure
Mortality rate
Deaths due to any cause are calculated.
Time frame: 30±7 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 with Likert score ≥ 12 points.
Time frame: intra-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, malfunctions, etc.
Time frame: intra-procedure, 360±30 days post-procedure