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

Suzhou Zenith Vascular Scitech

Status: Enrolling

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

Treatments: Device: Carotid Wallstent; Device: Timing Carotid Stent

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05574972

ZTYL202201

Details and patient eligibility

About

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

Full 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.

Enrollment: 178 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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 -

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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178 participants in 2 patient groups

Timing Carotid Stent

Experimental group

Treatment:

Device: Timing Carotid Stent

Carotid Wallstent

Active Comparator group

Treatment:

Device: Carotid Wallstent