Evaluate the safety and efficacy of the Timing Carotid Stent for the treatment of carotid artery stenosis in patients.
This is a prospective, randomized, concurrent controlled, multi-center study. Patients with carotid artery stenosis will be assigned to either the Timing Carotid Stent or Carotid Wallstent. Each treated patient will be followed and assessed for 12 months after randomization. The hypothesis to be tested is that the safety and effectiveness of the Timing Carotid Stent is not inferior to the Carotid Wallstent.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
178
all the participants in this group will be performed with Timing Carotid Stent
all the participants in this group will be performed with Carotid Wallstent
Xuanwu Hospital
Beijing, China
RECRUITINGNumber of Participants Who Experienced Major Adverse Events (MAE) at 30 days
MAE defined as any death, stroke, or myocardial infarction through 30 days post-index procedure
Time frame: 30 days
Number of Participants Who Achieved Stent Technical Success
Stent Technical Success defined as successful implantation of a Carotid Stent
Time frame: Procedural
Number of Participants Who Achieved Procedure Success
Number of Participants Who Achieved Procedure Success
Time frame: Procedural
Target Lesion Revascularization
Any clinically driven revascularization procedure that is performed to increase the luminal diameter inside or within 5 mm of the previously treated lesion
Time frame: 30 days
In-Stent Restenosis
≥50% diameter stenosis within the stented lesion or within 5 mm proximal or distal to the stent at follow-up evaluation
Time frame: 1 year
Ipsilateral ischemic stroke
Any ipsilateral ischemic stroke through 1 year post-index procedure
Time frame: 1 year
mRS score change
mRS score change through 1 year post-index procedure
Time frame: 1 year
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