Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to assess the efficacy and safety of the Flow Diverter (Tonbridge) for endovascular treatment of intracranial aneurysms.
This is a prospective, multi-center, randomized, open, positive-controlled, non-inferiority trial. This clinical trial is conducted at more than 5 centers in China. Eligible patients are randomized into experimental group using Flow Diverter (Tonbridge) or control group using Tubridge (MicroPort) in a 1:1 ratio. The primary objective of this study is to verify the complete occlusion rate of aneurysms at 12 months of Flow Diverter (Tonbridge) is non-inferior to Tubridge, for treatment of intracranial aneurysms, and evaluate the effectiveness and safety of the Flow Diverter (Tonbridge).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Flow Diverter (Tonbridge) | Experimental | Treatment with Flow Diverter (Tonbridge) |
|
| Tubridge (MicroPort) | Active Comparator | Treatment with Tubridge (MicroPort) |
|
| 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±45 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jianmin Liu | Changhai Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of USTC | Hefei | Anhui | China | |||
| Nanfang Hospital Southern Medical University |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Tubridge (MicroPort) | Device | Tubridge consists of a stent system and a microcatheter system. The stent system consists of a stent and a conveyor, the stent is self-expanding as well. |
|
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 |
| Subtotal occlusion rate | Subtotal occlusion is defined as contrast agents in the aneurysm sac less than 10% which is diagnosed by DSA at 12 months post-procedure. | 360±45 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 stroke | Stroke includes hemorrhagic stroke and symptomatic ischemic stroke. | within 360±45 days |
| Incidence of parent artery stenosis ( > 50%) in target area at 360 days and incidence of parent artery occlusion in target area at 360 days | Parent artery stenosis in target area is defined as stenosis degree > 50%. Using postoperative cerebrovascular DSA at 360 days is performed to determine. | 360±45 days post-procedure |
| Incidence of adverse events and incidence of serious adverse events | "Incidence of adverse events" is the proportion of subjects with adverse events using the investigational device or the comparator; "Incidence of serious adverse events" is the proportion of subjects with serious adverse events using the investigational device or the comparator. | within 360±45 days |
| Mortality rate | Deaths due to any cause are calculated. | within 360±45 days |
| 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 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. | within 360±45 days |
| Guangzhou |
| Guangdong |
| China |
| Zhujiang Hospital of Southern Medical University | Guangzhou | Guangdong | China |
| Nanyang Central Hospital | Nanyang | Henan | China |
| The First Affiliated Hospital of Zhengzhou University | Zhengzhou | Henan | China |
| Yichang Central People's Hospital | Yichang | Hubei | China |
| Hunan Provincial People's Hospital | Changsha | Hunan | China |
| Jiangsu Province Hospital | Nanjing | Jiangsu | China |
| The Second Affiliated Hospital of Nanchang University | Nanchang | Jiangxi | China |
| The Second Affiliated Hospital Zhejiang University School of Medicine | Hangzhou | Zhejiang | China |
| Zhejiang Hospital | Hangzhou | Zhejiang | China |
| Changhai Hospital of Shanghai | Shanghai | China |
| Huashan Hospital Fudan University | Shanghai | China |
| ID | Term |
|---|---|
| D002532 | Intracranial Aneurysm |
| ID | Term |
|---|---|
| D020765 | Intracranial Arterial Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided