carotid artery stenosis
Conditions
Interventions
Experimental group:CEA with bovine pericardium patch closure
Control group:CEA with chemical synthetic patch closure
Sponsors
Xuanwu hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Asymptomatic and preoperative imaging examinations suggest that carotid artery stenosis is =70% or symptomatic and carotid artery stenosis is >50%, the final diagnostic criterion before inclusion is CTA; 2.Physical condition and vital signs meet the requirements of surgery; 3.The included patients are willing to abide by the trial protocol and have the ability to return visits and check regularly; 4.The subjects understand and/or their guardians and voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1.The expected survival period is less than 1 year; 2.Those who cannot tolerate anesthesia; 3.Those who cannot complete CTA of blood vessels in the head and neck; 4.A large-scale stroke or myocardial infarction occurred within 30 days; 5.People with coagulation dysfunction and contraindications to heparin and antiplatelet drugs; 6.Has a recent history of gastrointestinal bleeding and is difficult to treat with antiplatelet drugs; 7.Patients with large intracranial aneurysms that cannot be treated in advance or at the same time; 8.Chronic complete occlusion without obvious symptoms of cerebral ischemia; 9.A history of intracranial hemorrhage (intraparenchymal hemorrhage, subarachnoid hemorrhage, subdural or epidural) within 30 days before enrollment; 10.Combined with severe liver, kidney, circulatory system and other diseases; 11.Severe dementia or mental disorder cannot be followed up in clinic; 12.Those who are currently participating in other clinical trials within 3 months; 13.The researcher believes that there are other reasons not suitable for the group.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Freedom from post-CEA restenosis (=50%) measured by color duplex or CTA ; | — |
Secondary
| Measure | Time frame |
|---|---|
| Postoperative cranial nerve injury, myocardial infarction, heart failure, ischemic stroke, hemorrhagic stroke, transient ischemic attacks (TIA), and surgical site infection and/or hematoma requiring surgical re-exploration and patch dilatation/rupture.; | — |
Countries
China
Contacts
Public ContactLiqun Jiao
Xuanwu hospital, Capital Medical University
Outcome results
None listed