Clinical trial NCT05574972: Timing Carotid Stent Clinical Study for the Treatment of Carotid Artery Stenosis（Timing 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）
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Carotid Artery Diseases
Carotid Artery Stenosis
Stroke
Ischemic Stroke
Lead sponsor: Suzhou Zenith Vascular Scitech Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Xuanwu Hospital, Beijing
First posted: 2022-10-12
Enrollment: 178
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 -

Primary outcomes:
measure: Number of Participants Who Experienced Major Adverse Events (MAE) at 30 days
timeFrame: 30 days
Secondary outcomes:
measure: Number of Participants Who Achieved Stent Technical Success
timeFrame: Procedural
measure: Number of Participants Who Achieved Procedure Success
timeFrame: Procedural
measure: Target Lesion Revascularization
timeFrame: 30 days
measure: In-Stent Restenosis
timeFrame: 1 year
measure: Ipsilateral ischemic stroke
timeFrame: 1 year
measure: mRS score change
timeFrame: 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xuanwu Hospital
Study officials:
References: