The purpose of this prospective, multicenter, single-group target-value study is to evaluate the safety and efficacy of the carotid artery stent system in patients with high-risk features for carotid endarterectomy. This trial is utilizing the carotid artery stent system provided by Shanghai HeartCare Medical Technology Co., Ltd. and will be conducted at approximately 10 interventional neurology centers in China.
This trial is a prospective, multicenter, single-group target-value study to evaluate the safety and efficacy of the carotid artery stent system in patients with high-risk features for carotid endarterectomy. The primary outcome is a composite outcome that includes stroke or death within 30 days after enrollment or after a revascularization procedure for the qualifying lesion during the follow-up period or ischemic stroke in the territory of the qualifying artery between day 31 and the end of the follow-up period.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
212
The carotid artery stent system consists of a nitinol self-expanding stent and a 1.65mm (5F) delivery device. At the tip of the delivery device and the inner part of the distal outer tube, there is a guidewire channel. The proximal end of the guidewire channel stops at the guidewire exchange port. The design allows for the accommodation of a guidewire with a diameter of 0.014inch (0.36mm).
Stroke, myocardial infarction, and death within 30 days after the procedure, or stroke in the territory of the ipsilateral artery between day 31 and day 365 after the procedure
Stroke is defined as an event that causes focal neurological dysfunction or signs and lasts for at least 24 hours, including ischemic stroke and hemorrhagic stroke. Myocardial infarction is defined as an increase in creatine kinase isoenzyme (CK-MB) or troponin in the postoperative period that is at least twice the upper limit of the normal range, accompanied by ischemic symptoms such as chest pain, or the presence of ischemic electrocardiogram evidence. Ischemic stroke in the territory of the ipsilateral artery is defined as an ischemic stroke in the cerebral hemisphere that is supplied with blood flow by the target artery.
Time frame: 30 days after the procedure and 365 days after the procedure
In-stent restenosis rate within 12 months after the procedure
Angiography demonstrated restenosis of the target artery both within the 5-mm stent segment and at the stent margins, with a degree of stenosis ≥50%.
Time frame: 365 days after the procedure
Implantation success rate
Implantation success was defined as successful implantation of the stent (including delivery, release, and expansion), covering the target lesion area, and subsequent withdrawal of the delivery system.
Time frame: During the procedure
Procedure success rate
Procedure success is defined as successful stent implantation followed by angiographic confirmation of ≤30% residual stenosis at the target lesion and the absence of any major adverse event prior to hospital discharge.
Time frame: Before the discharge or 7 days after the procedure
In-stent restenosis rate within 6 months after the procedure
Angiography demonstrated restenosis of the target artery both within the 5-mm stent segment and at the stent margins, with a degree of stenosis ≥50%.
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Time frame: 6 months after the procedure
Symptomatic in-stent restenosis rate
Symptomatic in-stent restenosis is defined as in-stent restenosis that results in an ischemic stroke or transient ischemic attack in the territory of the target artery.
Time frame: 6 months, and 12 months after the procedure
Target lesion revascularization rate
Target lesion revascularization is defined as any repeat revascularization procedure performed on the original treatment site, encompassing the initial lesion segment and a 5-mm border zone proximal and distal to it.
Time frame: 30 days, 6 months, and 12 months after the procedure
Ischemic stroke in the territory of the ipsilateral artery between day 31 and day 365 after the procedure
Ischemic stroke is defined as a new focal neurological deficit of sudden onset that is associated with an infarction lesion on CT or MRI.
Time frame: 12 months after the procedure