Bare-metal Stent vs Covered Stent in Chinese Patients With Subclavian Occlusive Lesions

Inclusion Criteria:

1. Age≥50 years，sex unlimited；

2. Left subclavian artery disease；

3. The cause of clinical considerations is arteriosclerosis ；

4. The presence of target organ ischemic symptoms, ie dizziness, headache, transientischemic attack (TIA), stroke, or other related neurological symptoms caused byischemia of the vertebral artery in the past 6 months, or the presence of arterialstenosis beyond the upper extremity limb ischemia symptoms subclavian；

5. The patient understands the trial objective, understands and accepts the duration ofthe study，is able and willing to comply with all requirements，including follow-up andevaluation of it, voluntarily participates in the study and signs Informed ConsentForm. Anatomy Criteria

6. Subclavian artery independent disease（Do not merge carotid or vertebral artery disease ）；

7. Subclavian artery satisfies one of the following criteria：

8. a) Ultrasonography suggests stenosis ≥ 70%，or CT ANGIOGRAM / angiography showedstenosis ≥ 70%；

9. Iconography examination confirmed vertebral artery steals；

10. Length of lesion is not involved in vertebral artery opening；

11. Lesions in subclavian artery the beginning portion；

12. The stent can reach the site of lesion smoothly as expected.

Exclusion Criteria:

1. Patients with anesthesia contraindications；

2. Serious ipsilateral stroke occurred in the past and may confuse the judgment of thestudy endpoint ；

3. Patients with severe dementia ；

4. Patients with spontaneous intracerebral hemorrhage in the past 12 months ；

5. Patients stroke episodes recently， CT or MRI suggested that the lesion is large，andmay be with the risk of hemorrhagic transformation ；

6. Large size of cerebral infarction or myocardial infarction occurred within 30 days ；

7. Patients with large intracranial aneurysms (diameter> 5mm)，and cannot be treated inadvance or contemporaneous ；

8. Chronic total occlusion without obvious cerebral ischemia symptoms ；

9. Patients with hemorrhagic transformation of cerebral arterial thrombosis within 60days before surgery ；

10. Hemoglobin <100 g/l， Platelet count ＜125×109/L， INR＞1.5， Bleeding time > 1min，patients with exceeding the upper limits of normal，or heparin-relatedthrombocytopenia ；

11. Patients unable to perform normal angiographic evaluation or unsafe percutaneouspuncture poin；

12. Patients with neurologic disorder that caused transient or permanent neurologicaldeficits within 2 years before the surgery and can not be identified with TIA orstroke ；

13. Patients with other cardiac emboli sources, such as left ventricular aneurysm,intraluminal filling defect, cardiomyopathy, aortic or mitral prosthetic heart valve,calcific aortic stenosis, infective endocarditis, mitral stenosis, atrial septaldefect, atrial septal aneurysm, or left atrial myxoma；

14. Surgical contraindications or patients with high risk of surgery defined as having anyof the following；It is known that two or more proximal or main coronary arterystenosis ≥70%, untreated or unable to pass；Ejection fraction <30% or New York HeartAssociation (NYHA) functional class III or higher；Unstable angina，ie angina at restingstate and electrocardiogram changes；Currently waiting main organ transplants (ieheart, lung, liver, kidney), or are doing relevant evaluate；Malignant tumor orrespiratory insufficiency, life expectancy < 5 years or FORCED EXPIRATORY VOLUME ATONE SECOND < 30% (predicted)；Dialysis-dependent renal failure； Need to perform othergeneral anesthesia during the same period ；

15. There may be one or more anatomical conditions affecting the normal operative approachin patients； there may be one or more anatomic situations to increase the risk ofadverse events in patients with high operative risk；including： Neck radiation therapyhistory； Radical neck surgery history；Subclavian artery dissection；Lesionsseries；Severe long segment calcification of the subclavian artery and severe stenosisor occlusion of the basilar artery；Inaccessible lesions by endoluminal methods (Severedistortion of the aortic arch branch, no suitable introduction of arteries, aorticarch anatomy special）；

16. Investigators consider the patient inappropriate to participate in this clinicaltrial；

17. Those who participated in clinical trials of other drugs or medical devices before theinclusion did not reach the end of the time limit.

18. Rheumatic immune diseases, such as Takayasu arteritis.