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This is a prospective multicenter, single-arm objective performance criteria trial to assess the efficacy and safety of the the thrombus aspiration catheter.
The study is conducted in 15 centers all around China, aiming at recruiting 155 patients with acute stroke caused by artery occlusion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aspiration thrombectomy | Experimental | Since this is a single-arm objective performance criteria trial, patients with acute stoke caused by artery occlusion shall not be divided into two groups. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thrombus Aspiration Catheter(Ton-bridgeMT) | Device | Thrombus Aspiration Catheter is a developed technique for treating acute stroke caused by artery occlusion. The catheter(Ton-bridgeMT) was specially designed for those patients who experience acute stroke within 24 hours. |
| Measure | Description | Time Frame |
|---|---|---|
| Successful recanalization rate within three-times aspiration | Successful recanalization is defined as modified Thrombolysis In Cerebral Infarction scale(mTICI) 2b or 3 evaluated by Digital subtraction angiography (DSA). | Up to 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Successful recanalization rate within three-times aspiration | Successful recanalization is defined as mTICI 2b or 3 evaluated by DSA. | Intraoperation |
| Successful recanalization rate beyond three-times aspiration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Liqun Jiao | Xuanwu Hospital, Beijing | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of USTC | Hefei | Anhui | China | |||
| Zhuhai people's hospital |
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Successful recanalization is defined as mTICI 2b or 3 evaluated by DSA. Auxiliary device such as stent could be used.
| Intraoperation |
| National Institute of Health stroke scale(NIHSS) | NIHSS score in 72 hours and 7 days(or the day when patients discharged, depends on which day is earlier) will be compared. | 72 hours / 7 days |
| Rate of Modified Rankin Scale(mRS) score less than 3 | The mRS score is assessed in 90 days follow-up. | 90 days |
| Device delivery performance | Device delivery performance including transport and pullback performance, which is ranked excellent/good/normal/bad. | Intraoperation |
| The rate of symptomatic intracranial hemorrhage | National Institute of Health stroke scale(NIHSS) increased by at least 4 compared with the baseline. | 72 hours |
| Death rate | Subjects who died from any cause would be counted. | Up to 90 days |
| The rate of AE | The definition of AE(Adverse Event) refers to ISO 14155 | Up to 90 days |
| The rate of SAE | The definition of SAE (Serious Adverse Event) refers to ISO 14155 | Up to 90 days |
| The rate of medical device deficiency | Medical device deficiency refer to the unreasonable risks of medical devices that may endanger human health and life safety under normal use in the process of clinical trials, such as label errors, quality problems, malfunctions, etc. | Up to 90 days |
| Zhuhai |
| Guangdong |
| China |
| The Second Nanning People's hospital | Nanning | Guangxi | China |
| Cangzhou central hospital | Cangzhou | Hebei | China |
| Hunan Provincial People's Hospital | Changsha | Hunan | China |
| Ganzhou Municipal Hospital | Ganzhou | Jiangxi | China |
| Central Hospital Affiliated to Shangdong First Medical University | Jinan | Shandong | China |
| First People's Hospital of Jinan | Jinan | Shandong | China |
| The Second People's Hospital of Liaocheng | Liaocheng | Shandong | China |
| Rizhao central Hospital | Rizhao | Shandong | China |
| Shanxi Candiovascular hospital | Taiyuan | Shanxi | China |
| School of medicine UESTC | Chengdu | Sichuan | China |
| Zigong Third People's Hospital | Zigong | Sichuan | China |
| The Second Affiliated Hospital of Zhejiang University School of Medicine | Hangzhou | Zhejiang | China |
| Xuanwu hospital Capital Medical University | Beijing | China |
| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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