Timing Carotid Stent Clinical Study for the Treatment of Carotid Artery Stenosis（Timing Trial）

Study Overview
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Brief Summary
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Evaluate the safety and efficacy of the Timing Carotid Stent for the treatment of carotid artery stenosis in patients.

Detailed Description
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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.

Official Title
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A Prospective, Multi-center and Randomized Controlled Clinical Trial to Evaluate the Efficacy and Safety of Timing Carotid Stent for Carotid Artery Stenosis（Timing Trial）

Conditions
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Carotid Artery Diseases, Carotid Artery Stenosis, Stroke, Ischemic Stroke

Intervention / Treatment
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* Device: Timing Carotid Stent
* Device: Carotid Wallstent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 18-85 years; Patient is either symptomatic with carotid stenosis ≥50% OR asymptomatic with carotid stenosis ≥70% ; Target lesion 3.5- 5.5 mm; Signed informed consent. Exclusion Criteria: Target lesion is not caused by atherosclerotic disease； Target lesion is located at the opening of the common carotid artery； Patient has severe lesion calcification that may restrict the full deployment of the carotid Patient has a total occlusion of the target carotid arteries Patient has a large number of acute or subacute thrombi and arteriovenous malformations near the target lesion Patient has a severe stenosis or occlusion in series with target lesions Patient has known severe carotid stenosis contralateral to the target lesion Patient need angioplasty in other parts (including intracranial and extracranial) at the same time or within 30 days after procedure Patient has a symptomatic severe stenosis of other blood vessels (including intracranial and extracranial) except carotid artery Patient is experiencing (or has experienced) an evolving, acute, or recent disabling stroke or intracranial hemorrhage Patient has a massive stroke or myocardial infarction Patient has a intracranial aneurysm Patient has a coagulation dysfunction or abnormal bleeding, or contraindications to heparin and antiplatelet drugs Patient has known sensitivity to contrast agent Patient has a platelet < 90 × 109 / L, severe liver and kidney injury, and severe dysfunction of important organs such as heart, lung, liver and kidney Patient has a uncontrollable severe hyperemia Patient has a bradycardia mRS≥3 Patient has life expectancy of less than one year Patient is currently enrolled in another investigational study protocol Females who are pregnant or in lactation Other conditions not suitable for inclusion judged by the researcher -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Timing Carotid Stent<br> | Device: Timing Carotid Stent<br>* all the participants in this group will be performed with Timing Carotid Stent<br>|
| Active Comparator: Carotid Wallstent<br> | Device: Carotid Wallstent<br>* all the participants in this group will be performed with Carotid Wallstent<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number 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 | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Achieved Stent Technical Success | Stent Technical Success defined as successful implantation of a Carotid Stent | Procedural | 
| Number of Participants Who Achieved Procedure Success | Number of Participants Who Achieved Procedure Success | 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 | 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 | 1 year | 
| Ipsilateral ischemic stroke | Any ipsilateral ischemic stroke through 1 year post-index procedure | 1 year | 
| mRS score change | mRS score change through 1 year post-index procedure | 1 year |