An interventional study of Thrombus Aspiration Catheter(Ton-bridgeMT) in Acute Ischemic Stroke, sponsored by Ton-Bridge Medical Tech. Co., Ltd. Completed at 15 sites in China. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by Ton-Bridge Medical Tech. Co., Ltd · Not applicable, Interventional, and Treatment
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.
2,653 studies on the registry are indexed under Ischemic Stroke; 936 are open to participants now.
This study's enrollment of 124 is close to the median of 120 across 1,799 interventional studies indexed under Ischemic Stroke.
Browse Ischemic Stroke studies →Ton-Bridge Medical Tech. Co., Ltd is the lead sponsor of 7 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
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.
Device: Thrombus Aspiration Catheter(Ton-bridgeMT)
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.
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
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
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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Ton-Bridge Medical Tech. Co., Ltd