Phase
Condition
Carotid Artery Disease
Treatment
N/AClinical Study ID
Ages 40-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 otherneurological symptoms in the past 6 months;
- Patients who could complete 12 months of follow-up;
- Patients who signed informed consent forms.
Exclusion
Exclusion Criteria:
- Patients who had a TIA, stroke, or other related neurological symptoms within theprevious 6 months;
- Patients with spontaneous intracerebral hemorrhage in the past 12 months;
- Patients with large intracranial aneurysms (diameter> 5mm),and cannot be treated inadvance or contemporaneous;
- Chronic total occlusion without obvious cerebral ischemia symptoms;
- Patients with neurologic disorder that caused transient or permanent neurologicaldeficits 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;
- Myocardial infarction occurred within 30 days;
- It is known that two or more proximal or main coronary artery stenosis ≥70%, untreatedor unable to recanalize;
- Ejection fraction <30% or New York Heart Association (NYHA) functional class III orhigher;Unstable angina,ie angina at resting state and electrocardiogram changes;
- Patients with cardiac emboli sources, such as left ventricular aneurysm, intraluminalfilling defect, cardiomyopathy, aortic or mitral prosthetic heart valve, calcificaortic stenosis, infective endocarditis, mitral stenosis, atrial septal defect, atrialseptal aneurysm, or left atrial myxoma;
- Platelet count <5×104/μL, INR>1.5, Bleeding time > 1 min, or heparin-relatedthrombocytopenia;Patients contraindicated to heparin and antiplatelet drugs;
- Patients with coagulation dysfunction.
- Poor control of diabetes, fasting blood glucose >22mmol/L and ketone body > +2;
- Malignant tumor or respiratory insufficiency, life expectancy < 5 years.
- Insufficiency of vital organs: forced expiratory volume at one second < 30% (predicted); dialysis-dependent renal failure; intolerance to anesthesia;
- Currently waiting main organ transplants (ie heart, lung, liver, kidney), or are doingrelevant evaluate;
- Need to perform other general anesthesia surgery during the same period;
- Pregnant or lactating women;
- Those who participated in clinical trials of other drugs or medical devices before theinclusion did not reach the end of the time limit;
- Investigators consider the patient inappropriate to participate in this clinicaltrial;
Study Design
Study Description
Connect with a study center
China-Japan Friendship Hospital
Beijing, Beijing 100192
ChinaActive - Recruiting
Peking Union Medical College Hospital
Beijing, Beijing 100032
ChinaActive - Recruiting
Xuanwu Hospital, Capital Medical University
Beijing, Beijing 100053
ChinaActive - Recruiting
Hebei General Hospital
Shijiazhuang, Hebei 050057
ChinaActive - Recruiting
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei 050000
ChinaActive - Recruiting
The Fifth Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan 450052
ChinaActive - Recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan 450000
ChinaActive - Recruiting
Nanjing Drum Tower Hospital
Nanjing, Jiangsu 210008
ChinaActive - Recruiting
First Affiliated Hospital Xi'an Jiaotong University
Xi'an, Shaanxi 710061
ChinaActive - Recruiting
Shanghai Changhai Hospital
Shanghai, Shanghai 200000
ChinaActive - Recruiting
People's Hospital of Xinjiang Uygur Autonomous Region
Urumqi, Xinjiang 830011
ChinaActive - Recruiting

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