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| Name | Class |
|---|---|
| Guangzhou Osmunda Medical Device Technology, Inc., Ltd. | INDUSTRY |
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The study is a prospective, multi-center, stratified randomized, single-blind, parallel assignment, active control, non-inferiority trial. Patients are randomized 1 : 1 to either stent retriever(TonbridgeMT) or Solitaire™ for endovascular therapy for AIS. The study aims to evaluate the benefit and safety of stent retriever(TonbridgeMT) for AIS therapy, as compared to Solitaire™.
The main objective is to determine whether stent retriever(TonbridgeMT) will have non-inferior successful recanalization rate compared to Solitaire™ when applied to endovascular therapy for AIS.
The secondary objectives is to verify whether there isn't significant differences in time to achieve recanalization, NIHSS score, mRS score, and transportation performance between stent retriever(TonbridgeMT) and Solitaire™ when applied to endovascular therapy for AIS.
The third objectives is to verify whether there isn't significant differences in the rate of symptomatic intracranial hemorrhage, subarachnoid hemorrhage, adverse event(AE), serious adverse event(SAE), actual condition of AE and device deficiencies between stent retriever(TonbridgeMT) and Solitaire™ when applied to endovascular therapy for AIS.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| group A | Experimental | subjects applying the stent retriever(TonbridgeMT) |
|
| group B | Active Comparator | subjects applying Solitaire™ |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| stent retriever(TonbridgeMT) | Device | mechanical thrombectomy with stent retriever(TonbridgeMT), digital subtraction angiography(DSA), computed tomography(CT), magnetic resonance imaging (MRI), diffusion weighted imaging (DWI) |
| Measure | Description | Time Frame |
|---|---|---|
| successful recanalization rate in patients | Successful recanalization is defined as modified Thrombolysis In Cerebral Ischemia scale 2b or 3. And it is evaluated by DSA intraoperative immediately in both treatment groups | intraoperative immediate |
| Measure | Description | Time Frame |
|---|---|---|
| successful recanalization rate in vessels | The proportion of successful recanalized vessels in all targeted vessels which receive the stent retriever treatment | intraoperative immediate |
| Time to achieve recanalization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jianmin Liu | Changhai Hospital of Shangha | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Changhai Hospital of Shanghai | Shanghai | Shanghai Municipality | China | |||
| The 306th Hospital of Chinese PLA |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34456847 | Derived | Zhang Y, Hua W, Li Z, Peng Y, Han Z, Li T, Yin C, Wang S, Nan G, Zhao Z, Yang H, Zhou B, Li T, Cai Y, Zhang J, Li G, Peng X, Guan S, Zhou J, Ye M, Wang L, Zhang L, Hong B, Zhang Y, Wan J, Wang Y, Zhu Q, Liu J, Yang P. Efficacy and Safety of a Novel Thrombectomy Device in Patients With Acute Ischemic Stroke: A Randomized Controlled Trial. Front Neurol. 2021 Aug 12;12:686253. doi: 10.3389/fneur.2021.686253. eCollection 2021. |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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prospective, stratified-randomized, single-blind, parallel assignment, active control
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| Solitaire™ | Device | mechanical thrombectomy with Solitaire™ , digital subtraction angiography(DSA), computed tomography(CT), magnetic resonance imaging(MRI), diffusion weighted imaging(DWI) |
|
The period from femoral artery puncture to successful recanalization
| intraoperative immediate |
| NIHSS score | National Institutes of Health Stroke Scale | baseline, 24±6d and 7±2d after operation |
| mRS score | The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. | baseline, 90±14d after operation |
| the ratio of mRS 0-2 | The proportion of patients who got a mRS 0-2 in patients who receive stent retriever treatment | baseline, 90±14d after operation |
| transportation performance | The proportion of stent retriever which can push and draw back well during the operation. The operator will grade each stent retriever at four level, namely great, good, average,and bad | intraoperative immediate |
| Beijing |
| China |
| China-Japan union hospital | Changchun | China |
| The First Hospital of Jilin University | Changchun | China |
| The First People's Hospital of Changzhou | Changzhou | China |
| The Second Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine | Guangzhou | China |
| The Affiliated Hospital of Guizhou Medical University | Guiyang | China |
| Hangzhou First People's Hospital | Hangzhou | China |
| The Second Affiliated hospital of Zhejiang University School of Medicine | Hanzhou | China |
| Nanjing First Hospital Affiliated to Nanjing Medicine University | Nanjing | China |
| Nanning People's Hospital | Nanning | China |
| The Third People's Hospital of Hubei Province | Wuhan | China |
| Tangdu Hospital | Xi'an | China |
| Henan Provincial People's Hospital | Zhengzhou | China |
| The First Affiliated Hospital of Zhengzhou University | Zhengzhou | China |
| Zhongshan People's Hospital | Zhongshan | China |
| The Fifth Affiliated Hospital Sun Yat-sen University | Zhuhai | China |
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |