Evaluating a new carotid stent for treating carotid artery stenosis

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）

This study is testing a new type of carotid stent to see if it is just as safe and effective as a current stent for people with narrowed carotid arteries.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 178 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Suzhou Zenith Vascular Scitech Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Beijing)
• Trial ID: NCT05574972 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the safety and efficacy of the Timing Carotid Stent compared to the Carotid Wallstent in patients with carotid artery stenosis. It is a prospective, randomized, concurrent controlled, multi-center study where eligible patients will be assigned to one of the two stent types. Participants will be monitored for 12 months post-randomization to evaluate outcomes. The study seeks to determine if the Timing Carotid Stent is as safe and effective as the established Carotid Wallstent.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-85 with symptomatic carotid stenosis of 50% or greater, or asymptomatic stenosis of 70% or greater.

Not a fit: Patients with carotid lesions not caused by atherosclerosis, or those with severe calcification or occlusions, may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients with carotid artery stenosis, potentially improving outcomes and reducing the risk of stroke.

How similar studies have performed: Other studies have shown success with similar stent approaches, indicating potential for this new device.

Eligibility criteria

Inclusion Criteria:

1. Aged 18-85 years;
2. Patient is either symptomatic with carotid stenosis ≥50% OR asymptomatic with carotid stenosis ≥70% ;
3. Target lesion 3.5- 5.5 mm;
4. Signed informed consent.

Exclusion Criteria:

1. Target lesion is not caused by atherosclerotic disease；
2. Target lesion is located at the opening of the common carotid artery；
3. Patient has severe lesion calcification that may restrict the full deployment of the carotid
4. Patient has a total occlusion of the target carotid arteries
5. Patient has a large number of acute or subacute thrombi and arteriovenous malformations near the target lesion
6. Patient has a severe stenosis or occlusion in series with target lesions
7. Patient has known severe carotid stenosis contralateral to the target lesion
8. Patient need angioplasty in other parts (including intracranial and extracranial) at the same time or within 30 days after procedure
9. Patient has a symptomatic severe stenosis of other blood vessels (including intracranial and extracranial) except carotid artery
10. Patient is experiencing (or has experienced) an evolving, acute, or recent disabling stroke or intracranial hemorrhage
11. Patient has a massive stroke or myocardial infarction
12. Patient has a intracranial aneurysm
13. Patient has a coagulation dysfunction or abnormal bleeding, or contraindications to heparin and antiplatelet drugs
14. Patient has known sensitivity to contrast agent
15. 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
16. Patient has a uncontrollable severe hyperemia
17. Patient has a bradycardia
18. mRS≥3
19. Patient has life expectancy of less than one year
20. Patient is currently enrolled in another investigational study protocol
21. Females who are pregnant or in lactation
22. Other conditions not suitable for inclusion judged by the researcher -

Where this trial is running

Beijing

• Xuanwu Hospital — Beijing, China (Recruiting)

Conditions Carotid Artery Diseases; Carotid Artery Stenosis; Stroke; Ischemic Stroke