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

Stroke Clinical Trial

Official title:

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）

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05574972
• Other study ID #: ZTYL202201
• Status: Recruiting
• Phase: N/A
• Start date: October 18, 2022
• Est. completion date: May 30, 2025

Study information

• Verified date: January 2023
• Source: Suzhou Zenith Vascular Scitech Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 178
• Est. completion date: May 30, 2025
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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 -

Related Conditions & MeSH terms

• Carotid Artery Diseases
• Carotid Artery Stenosis
• Carotid Stenosis
• Constriction, Pathologic
• Ischemic Stroke
• Stroke

Intervention

Device:
• Timing Carotid Stent
all the participants in this group will be performed with Timing Carotid Stent
• Carotid Wallstent
all the participants in this group will be performed with Carotid Wallstent

Locations

Country	Name	City	State
China	Xuanwu Hospital	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Suzhou Zenith Vascular Scitech Co., Ltd.	Xuanwu Hospital, Beijing

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of Participants Who Achieved Stent Technical Success	Stent Technical Success defined as successful implantation of a Carotid Stent	Procedural
Secondary	Number of Participants Who Achieved Procedure Success	Number of Participants Who Achieved Procedure Success	Procedural
Secondary	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
Secondary	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
Secondary	Ipsilateral ischemic stroke	Any ipsilateral ischemic stroke through 1 year post-index procedure	1 year
Secondary	mRS score change	mRS score change through 1 year post-index procedure	1 year