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

NCT ID: NCT05574972

Last Updated: 2023-01-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 178 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-18
• Study Completion Date: 2025-05-30

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Timing Carotid Stent

Group Type: EXPERIMENTAL

Timing Carotid Stent

Intervention Type: DEVICE

all the participants in this group will be performed with Timing Carotid Stent

Carotid Wallstent

Group Type: ACTIVE_COMPARATOR

Carotid Wallstent

Intervention Type: DEVICE

all the participants in this group will be performed with Carotid Wallstent

Interventions

Timing Carotid Stent

all the participants in this group will be performed with Timing Carotid Stent

Intervention Type: DEVICE

Carotid Wallstent

all the participants in this group will be performed with Carotid Wallstent

Intervention Type: 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 -

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xuanwu Hospital, Beijing

OTHER

Sponsor Role: collaborator

Suzhou Zenith Vascular Scitech Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Xuanwu Hospital

Beijing, , China

Site Status: RECRUITING

Countries

China

Facility Contacts

Liqun Jiao

Role: primary

13911224991@139.com

+8601083198277

Other Identifiers

ZTYL202201

Identifier Type: -

Identifier Source: org_study_id