The purpose of this trial is to evaluate effectiveness and safety of the Ton-bridge carotid stent for the treatment of carotid artery stenosis.
This is a prospective, multicenter, open-label, non-inferiority, randomized controlled trial carried out in 7 research centers in China. Patients with carotid atherosclerotic stenosis will be randomized (1:1) to either the Ton-bridge carotid stent or WALLSTENT carotid stent for treatment. The purpose of this clinical trial is to evaluate the effectiveness and safety of a novel carotid stent, the Ton-bridge carotid stent, in humans for treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
188
carotid artery stenting with Ton-bridge carotid stent
carotid artery stenting with WALLSTENT carotid stent
The People's Hospital of Liaoning Province
Shenyang, Liaoning, China
Linyi People's Hospital
Linyi, Shandong, China
Qingdao Central Hospital
Qingdao, Shandong, China
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
Incidence of non-MAE(major adverse events) within 30 days post-procedure
MAE is defined as any death, stroke or myocardial infarction.
Time frame: Up to 30 days
Technical success
Proportion of participants who achieve technical success. Technical success is defined as successful implantation of the carotid stent and successful retraction of the delivery catheter.
Time frame: Intraprocedure
Procedural success
Proportion of participants who achieve procedural success. Procedural success is defined as stent technical success with \<50% residual stenosis and no MAE in-hospital or 7 days post-procedure.
Time frame: before discharge or up to 7 days
Target lesion revascularization (TLR) rate
TLR is defined as any invasive revascularization procedure that is performed to reperfuse or increase the luminal diameter of the vessel inside or within 5mm of the previously treated lesion.
Time frame: Up to 1 year
Ipsilateral stroke between 31 days and 1 year post-procedure
Incidence of any ipsilateral stroke between 31 days and 1 year post-procedure.
Time frame: Between 31 days and 1 year
In-stent restenosis rate
In-stent restenosis is defined as ≥50% diameter stenosis within the stented lesion or within 5mm proximal or distal to the stent.
Time frame: 180±30 days, 360±30 days
mRS score
Modified Rankin Scale (mRS) score of participants in every evaluation time point. The mRS score is generally to assess disability in patients who have suffered a stroke and ranges from 0 to 6. Higher scores mean a more severe disability. 6 means death.
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Central Hospital Affiliated to Shangdong First Medical University
Jinan, Shangdong, China
Lishui Central Hospital
Lishui, Zhejiang, China
Xuanwu Hospital, Capital Medical University
Beijing, China
Time frame: 30±7 days, 180±30 days, 360±30 days
Device deficiency
Defined as the unreasonable risk that may endanger human health and life safety in the normal use of medical devices during clinical investigations, such as labeling errors, quality problems, malfunctions, etc.
Time frame: Up to 1 year
Incidence of MAE
MAE is defined as any death, stroke or myocardial infarction.
Time frame: Up to 1 year
Incidence of Adverse events (AE)
Defined as untoward medical event occurring during the course of clinical investigation, whether or not related to the medical device.
Time frame: Up to 1 year
Incidence of Serious adverse events (SAE)
Defined as the event occurring during the course of clinical investigation, which leads to death or serious deterioration in the health, including a life-threatening illness or injury; a permanent impairment of a body structure or a body function; in-patient or prolonged hospitalization; medical or surgical intervention to prevent permanent impairment to a body structure or a body function; foetal distress, foetal death, congenital abnormality or birth defect, etc.
Time frame: Up to 1 year