Carotid Revascularization Versus Best Medical Treatment for Asymptomatic Carotid Stenosis: a Multicenter, Open, Randomized Controlled Trial in Chinese Population
Overview
- Phase
- N/A
- Intervention
- Carotid Revascularization
- Conditions
- Carotid Artery Stenting
- Sponsor
- Xuanwu Hospital, Beijing
- Enrollment
- 1056
- Locations
- 11
- Primary Endpoint
- Any Periprocedural Stroke, Myocardial Infarction, or Death During1 month Peri-procedural Period, and Postprocedural Ipsilateral Stroke 1 to 12-months.
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
This is a multicenter, open, randomized controlled trial to evaluate the efficacy and safety of carotid artery stenting/carotid endarterectomy versus best medical treatment for asymptomatic carotid artery stenosis in Chinese population.
Detailed Description
This is a multicenter, open, randomized controlled trial to evaluate the efficacy and safety of carotid artery stenting/carotid endarterectomy versus best medical treatment for asymptomatic carotid artery stenosis in Chinese population. The study will be conducted at 11 centers and is expected to enroll 1056 patients.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age 40-80 years;
- •Carotid artery stenosis 50%-90% (ultrasound, CT, or DSA);
- •Asymptomatic carotid stenosis, that is, no transient ischemic attack, stroke, or other neurological symptoms in the past 6 months;
- •Patients who could complete 12 months of follow-up;
- •Patients who signed informed consent forms.
Exclusion Criteria
- •Patients who had a TIA, stroke, or other related neurological symptoms within the previous 6 months;
- •Patients with spontaneous intracerebral hemorrhage in the past 12 months；
- •Patients with large intracranial aneurysms (diameter\> 5mm)，and cannot be treated in advance or contemporaneous;
- •Chronic total occlusion without obvious cerebral ischemia symptoms；
- •Patients with neurologic disorder that caused transient or permanent neurological deficits and can not be identified with transient ischemic attack or stroke；
- •Patients with severe dementia;
- •Common carotid artery opening lesion；
- •Severe intracranial stenosis in tandem;
- •Carotid artery dissection;
- •Carotid artery aneurysm;
Arms & Interventions
Carotid Revascularization
Carotid Artery Stenting/Carotid endarterectomy + Best Medical Treatment
Intervention: Carotid Revascularization
Carotid Revascularization
Carotid Artery Stenting/Carotid endarterectomy + Best Medical Treatment
Intervention: Medical Treatment
Medical Treatment
Best Medical Treatment
Intervention: Medical Treatment
Outcomes
Primary Outcomes
Any Periprocedural Stroke, Myocardial Infarction, or Death During1 month Peri-procedural Period, and Postprocedural Ipsilateral Stroke 1 to 12-months.
Time Frame: 0 to 12 months
Composite of any periprocedural stroke (ipsilateral or contralateral; major or minor), myocardial infarction, or death during1 month peri-procedural period, and postprocedural ipsilateral stroke 1 to 12-months.
Secondary Outcomes
- Carotid restenosis rate(12 months)
- Technical success rate(1 day)
- Rate of complications(30 days)
- Incidence of myocardial infarction(30 days)
- Incidence of ipsilateral stroke(30 days)
- Incidence of death(30 days)
- Incidence of target lesion revascularization(12 months)
- Improvement in cognitive function(12 months)