Carotid Stenosis
Conditions
Interventions
Test group :Carotid endarterectomy
Control group :Carotid artery stenting
Sponsors
Gusu College of Nanjing Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. patients aged 35 to 85 years old; 2. Carotid artery stenosis is defined as: stenosis by angiography (NASCET criteria) >= 70% (asymptomatic), or >= 50% (symptomatic); 3. Preoperative simple intelligence scale score> 22 points; 4. Within 180 days after randomization, if there is a history of ipsilateral stroke or TIA, it is symptomatic, otherwise, it is asymptomatic; 5. At the time of informed consent, the modified Rankin scale score is <= 2 points; 6. Women are infertile, or if fertile, have a negative pregnancy test prior to randomization; 7. The patient must agree to follow all protocol-specified follow-up appointments; 8. The patient must sign the consent form approved by the corresponding clinical site and local regulatory institutional review board (IRB)/medical ethics committee (MEC); 9. For patients with bilateral carotid artery stenosis, the random assignment of treatment groups is only applicable to one carotid artery; 10. Carotid artery stenosis treatable by carotid endarterectomy (CEA) or carotid artery stenting (CAS).
Exclusion criteria
Exclusion criteria: 1. No tolerance or allergic reaction to the study drug, and no other suitable options; 2. Hemorrhage in the gastrointestinal tract occurred within one month before enrollment, which may be contraindicated in antiplatelet therapy; 3. Intracranial hemorrhage in the past 12 months; 4. Current neurological disease characterized by transient or fixed neurological deficits indistinguishable from TIA or stroke; 5. The platelet count is less than 100000/ul or the history of heparin-induced thrombocytopenia; 6. Chronic atrial fibrillation; 7. Any occurrence of atrial fibrillation or paroxysmal atrial fibrillation within the past 6 months is considered to require long-term anticoagulation; 8. Other high-risk heart disease with emboli, including left ventricular aneurysm, severe cardiomyopathy, aortic or mitral mechanical heart valve, severe calcified aortic stenosis (valve area =2.5mg/dl or estimated GFR makes planning 5mm; 19. WHO grade III obesity (BMI>40kg/m2); 20. Coronary artery disease, with two or more stenosis or stenosis degree >=70% proximal or main coronary lesions, no or no revascularization.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cognitive function; | — |
Secondary
| Measure | Time frame |
|---|---|
| Composite prognostic index; | — |
Countries
China
Contacts
Public ContactZhou Dayong
Gusu College and Suzhou Hospital of Nanjing Medical University, Suzhou Municipal Hospital
Outcome results
None listed