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

Not Applicable

Recruiting

• Conditions: Stroke; Ischemic Stroke; Carotid Artery Diseases; Carotid Artery Stenosis
• Interventions: Device: Carotid Wallstent; Device: Timing Carotid Stent

• Registration Number: NCT05574972
• Lead Sponsor: Suzhou Zenith Vascular Scitech Co., Ltd.

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 Timeline

• Study First Submitted: 2022-10-07
• Study First Submitted QC: 2022-10-07
• Study First Posted: 2022-10-12
• Study Start: 2022-10-18
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-03
• Last Update Posted: 2023-01-04
• Primary Completion: 2024-12-30
• Study Completion: 2025-05-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 178

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 -

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Carotid Wallstent	Carotid Wallstent	-
Timing Carotid Stent	Timing Carotid Stent	-

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Experienced Major Adverse Events (MAE) at 30 days	30 days	MAE defined as any death, stroke, or myocardial infarction through 30 days post-index procedure

Secondary Outcome Measures

Name	Time	Method
Number of Participants Who Achieved Stent Technical Success	Procedural	Stent Technical Success defined as successful implantation of a Carotid Stent
Number of Participants Who Achieved Procedure Success	Procedural	Number of Participants Who Achieved Procedure Success
Ipsilateral ischemic stroke	1 year	Any ipsilateral ischemic stroke through 1 year post-index procedure
In-Stent Restenosis	1 year	≥50% diameter stenosis within the stented lesion or within 5 mm proximal or distal to the stent at follow-up evaluation
mRS score change	1 year	mRS score change through 1 year post-index procedure
Target Lesion Revascularization	30 days	Any clinically driven revascularization procedure that is performed to increase the luminal diameter inside or within 5 mm of the previously treated lesion

Trial Locations

Locations (1)

Xuanwu Hospital; 🇨🇳 Beijing, China