Carotid artery stenosis
Conditions
Interventions
Control group:PRECISE Nitinol Stent System
Sponsors
Henan Provincial People's Hospital/The Second Xiangya Hospital of Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Patient is between =18 and =80 years of age. 2. Patient who is diagnosed as carotid atherosclerotic stenosis 3. Intend to implant one stent during the procedure 4. Patient has a vessel with reference diameters between 4.0 mm and 9.0 mm at the target lesion 5. Patient has a modified Rankin Scale of=2 6. Patient signed the informed consent
Exclusion criteria
Exclusion criteria: 1. Patient has a previously placed arterial stent or has undergone carotid endarterectomy for the target lesion 2. patient has the floating thrombus in the target lesion. 3. Patient has a total occlusion of the target carotid arteries, or total occlusion contralateral to the target lesion 4. Patient needs treatment in nontarget artery with stenosis=70%( including intracranial and extracranial) at the same time or within 30 days after procedure 5. Patient has intracranial pathology 6. Patient does not have a suitable vascular pathway which would prevent the device from reaching the target vessel 7. Patient is experiencing (or has experienced) a progressive stroke 8. with symptomatic carotid artery stenosis has an increase in NIHSS score = 4 within one week. 9. Patient has a massive cerebral infarction 10. Patient has intracranial hemorrhage within the past 12 months 11. Patient has acute coronary syndrome within previous 30 days 12. Patient has anticipated or potential cardiac sources of emboli 13. Patient has severe bradycardia 14. Patient has severe dysfunction of important organs 15. Patient needs concurrent requirement for any major surgery 30 days pre- or post-procedure 16. Patient has uncontrolled hypertension prior to procedure 17. Patient has a platelet 1.5 without oral anticoagulant drugs, or uncorrected coagulation disorders. 18. Patient has mental disorder or a history of mental illness and is unable to cooperate independently 19. Patient is pregnant or breastfeeding 20. Patient has participated in another interventional study trial 21. Patient has other conditions not suitable for inclusion judged by the researcher
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of MAE within 30 days ; | — |
Secondary
| Measure | Time frame |
|---|---|
| Technical success rate;Procedure success rate ;Patency rate of target lesion within 6 months;The revascularization rate of target lesion within 6 months ;The incidence of ipsilateral stroke within 6 months ; | — |
Countries
China
Contacts
Public ContactTianxiao Li; ChangShu
Henan Provincial People's Hospital/The Second Xiangya Hospital of Central South University
Outcome results
None listed