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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Flow Diverter (Tonbridge) | Experimental | Treatment with Flow Diverter (Tonbridge) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Flow Diverter (Tonbridge) | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 360±30 days post-procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Immediate procedural success rate | Intraoperative cerebrovascular DSA is performed to determine whether the investigational device positions exactly and covers the aneurysm neck effectively. | intra-procedure |
| Complete occlusion rate of aneurysms at 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jianmin Liu | Changhai Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Wannan Medical College | Wuhu | Anhui | China | |||
| Henan Provincial People's Hospital |
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| ID | Term |
|---|---|
| D002532 | Intracranial Aneurysm |
| ID | Term |
|---|---|
| D020765 | Intracranial Arterial Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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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. |
| 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. | 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. | 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. | intra-procedure |
| Incidence of any stroke | Stroke includes hemorrhagic stroke and symptomatic ischemic stroke. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | intra-procedure, 360±30 days post-procedure |
| Zhengzhou |
| Henan |
| China |
| Nanjing Drum Tower Hospital | Nanjing | Jiangsu | China |
| Zhejiang Hospital | Hangzhou | Zhejiang | China |
| Xinqiao Hospital, Army Medical University | Chongqing | China |
| Changhai Hospital of Shanghai | Shanghai | China |
| Huashan Hospital Fudan University | Shanghai | China |
| D009422 | Nervous System Diseases |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |