Carotid artery stenosis
Conditions
Interventions
Control group :PRECISE Nitinol Stent System
Sponsors
The First Affiliated Hospital Of USTC(Anhui Provincial Hospital)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1)Subjects who agree to participate in this study and have signed informed consent form; (2)Age=18 years, and =80 years (regardless of gender); (3)Subjects who were diagnosed as carotid atherosclerotic stenosis and were suitable for endovascular interventional therapy; (4)The degree of symptomatic carotid artery stenosis (NASCET method) = 50%, or the degree of asymptomatic carotid artery stenosis (NASCET method) = 70% was confirmed by DSA during the operation.[Symptomatic is defined as a history of non-disabling ischemic stroke or transient ischemic attack (TIA, including hemisphere events or Transient monocular amaurosis) within 6 months]; (5)Target vessel reference diameter is 3.0 mm to 9.0 mm; (6)Subjects with mRS = 2 before enrollment; (7)Available for follow-up.
Exclusion criteria
Exclusion criteria: (1)Non-atherosclerotic diseases on target lesion; (2)Total occlusions of target lesion and/or opposite carotid artery; (3)Suffering from severe disability with ischemic stroke. (4)Adjacent areas of target lesion with a large number of acute or subacute thrombus and arteriovenous malformation; (5)Arterial tortuosity or severe calcification that would prevent the device from reaching the target vessel; (6)Patients with symptomatic severe stenosis of other ipsilateral blood vessels (including intracranial and extracranial) that the investigator considers inappropriate to participate in this trial; (7)Subjects requiring simultaneous or within 30 days received balloon dilation/stent implantation (including intracranial and extracranial artery) ; (8)Subjects with the tandem severe stenosis or occlusion of proximal or distal vessels at the target lesion . (9)Myocardial infarction or massive cerebral infarction within 2 weeks before screening; (10)Intracranial hemorrhage or progressive stroke within 3 months before screening; (11)Intracranial aneurysms requiring treatment; (12)Uncontrolled hypertension; (systolic blood pressure= 180mmHg or diastolic blood pressure = 110mmHg); (13)Platelet 3mg/dL, i.e. 265.2 umol/L), and severe dysfunction of important organs such as heart, lung, liver and kidney; (14)Coagulation dysfunction, and contraindications to heparin and antiplatelet drugs; (15)Allergic to the components and contrast agents of the test product; (16)Life expectancy<1 year; (17)Pregnant or lactating women; (18)Participating in other clinical trials; (19)Other situations not suitable to participate in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| There was no incidence of MAE within 30 days after CAS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Medical Device success rate;success rate of CAS;The revascularization rate of target lesion;The recurrence of stenosis ;The recurrence of ipsilateral ischemic stroke from the 31st days to the 1st year after operation;mRS score;Incidence rate of MAE within 6 months/12 months after CAS;Adverse event/Serious adverse event;Incidence of Medical devices defects; | — |
Countries
China
Contacts
Public ContactWei Hu
The First Affiliated Hospital Of USTC(Anhui Provincial Hospital)
Outcome results
None listed