Carotid Artery Diseases, Carotid Artery Stenosis, Ischemic Stroke, Stroke
Conditions
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.
Interventions
DEVICETiming Carotid Stent
all the participants in this group will be performed with Timing Carotid Stent
DEVICECarotid Wallstent
all the participants in this group will be performed with Carotid Wallstent
Sponsors
Xuanwu Hospital, Beijing
Suzhou Zenith Vascular Scitech Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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 -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| Ipsilateral ischemic stroke | 1 year | Any ipsilateral ischemic stroke through 1 year post-index procedure |
| mRS score change | 1 year | mRS score change through 1 year post-index procedure |
Countries
China
Outcome results
None listed