NCT05574972RecruitingNot Applicable
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）
Suzhou Zenith Vascular Scitech Co., Ltd.1 site in 1 country178 target enrollmentStarted: October 18, 2022Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 178
- Locations
- 1
- Primary Endpoint
- Number of Participants Who Experienced Major Adverse Events (MAE) at 30 days
Study Overview
Brief Summary
Evaluate the safety and efficacy of the Timing Carotid Stent for the treatment of carotid artery stenosis in patients.
Detailed Description
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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 -
Outcomes
Primary Outcomes
Number of Participants Who Experienced Major Adverse Events (MAE) at 30 days
Time Frame: 30 days
MAE defined as any death, stroke, or myocardial infarction through 30 days post-index procedure
Secondary Outcomes
- mRS score change(1 year)
- Number of Participants Who Achieved Stent Technical Success(Procedural)
- Number of Participants Who Achieved Procedure Success(Procedural)
- Ipsilateral ischemic stroke(1 year)
- In-Stent Restenosis(1 year)
- Target Lesion Revascularization(30 days)
Investigators
Study Sites (1)
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