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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
124
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.
The First Affiliated Hospital of USTC
Hefei, Anhui, China
Zhuhai people's hospital
Zhuhai, Guangdong, China
The Second Nanning People's hospital
Nanning, Guangxi, China
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).
Time frame: Up to 90 days
Successful recanalization rate within three-times aspiration
Successful recanalization is defined as mTICI 2b or 3 evaluated by DSA.
Time frame: Intraoperation
Successful recanalization rate beyond three-times aspiration
Successful recanalization is defined as mTICI 2b or 3 evaluated by DSA. Auxiliary device such as stent could be used.
Time frame: 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.
Time frame: 72 hours / 7 days
Rate of Modified Rankin Scale(mRS) score less than 3
The mRS score is assessed in 90 days follow-up.
Time frame: 90 days
Device delivery performance
Device delivery performance including transport and pullback performance, which is ranked excellent/good/normal/bad.
Time frame: Intraoperation
The rate of symptomatic intracranial hemorrhage
National Institute of Health stroke scale(NIHSS) increased by at least 4 compared with the baseline.
Time frame: 72 hours
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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
...and 5 more locations
Death rate
Subjects who died from any cause would be counted.
Time frame: Up to 90 days
The rate of AE
The definition of AE(Adverse Event) refers to ISO 14155
Time frame: Up to 90 days
The rate of SAE
The definition of SAE (Serious Adverse Event) refers to ISO 14155
Time frame: 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.
Time frame: Up to 90 days