Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Peking University First Hospital | OTHER |
| The First Affiliated Hospital of Dalian Medical University | OTHER |
| Shanghai Zhongshan Hospital | OTHER |
Not provided
Not provided
Not provided
Not provided
Bare-metal stent vs Covered stent with subclavian occlusive lesions to verify the efficacy and safety.Study Design are prospective, multiple center, randomized, open, positive controlled, non-inferiority trail.Case total numbers enrollment predict 408 cases,each group 204 cases.Follow up period for 1 years.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Covered stent group | Experimental | Covered stent |
|
| Bare-metal stent group | Active Comparator | Bare-metal stent |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stent implantation of subclavian artery | Procedure | Stent implantation of subclavian artery |
|
| Measure | Description | Time Frame |
|---|---|---|
| target lesion patency rate(%) | 12-month target lesion patency rate(%) | 1 years |
| Measure | Description | Time Frame |
|---|---|---|
| Surgery success rate | Surgery success rate | 1 day |
| Rate of complications | Rate of complications within 30 days; | 30 days |
Not provided
Inclusion Criteria:
Age≥50 years,sex unlimited;
Left subclavian artery disease;
The cause of clinical considerations is arteriosclerosis ;
The presence of target organ ischemic symptoms, ie dizziness, headache, transient ischemic attack (TIA), stroke, or other related neurological symptoms caused by ischemia of the vertebral artery in the past 6 months, or the presence of arterial stenosis beyond the upper extremity limb ischemia symptoms subclavian;
The patient understands the trial objective, understands and accepts the duration of the study,is able and willing to comply with all requirements,including follow-up and evaluation of it, voluntarily participates in the study and signs Informed Consent Form.
Anatomy Criteria
Subclavian artery independent disease(Do not merge carotid or vertebral artery disease );
Subclavian artery satisfies one of the following criteria:
The stent can reach the site of lesion smoothly as expected.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| YongQuan Gu YQ Gu, Prof. | Contact | +8615901598209 | guyongquan@xwhosp.org | |
| JianMing Guo JM Guo | Contact | +8613146369562 | guojianming@aliyun.com |
| Name | Affiliation | Role |
|---|---|---|
| YongQuan Gu YQ Gu, Prof. | Xuanwu Hospital, Beijing | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking hospital first University | Not yet recruiting | Beijing | 100000 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Xinhua Hospital, Shanghai Jiao Tong University School of Medicine |
| OTHER |
| Shanghai Changzheng Hospital | OTHER |
| First Affiliated Hospital Xi'an Jiaotong University | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
| Incidence of myocardial infarction | Incidence of myocardial infarction at 30 days follow up; | 30 days |
| Ipsilateral stroke and death rates | Ipsilateral stroke and death rates at 30 days follow up; | 30 days |
| Bilateral stroke and death rates | Bilateral stroke and death rates at 30 days follow up; | 30 days |
| Subclavian artery restenosis rate | Subclavian artery restenosis rate at 6、12 months follow up; | 6、12 months |
| Incidence of composite endpoints of myocardial infarction, stroke, and any death | Incidence of composite endpoints of myocardial infarction, stroke, and any death at 30 days | 30days |
| Incidence of composite endpoints of myocardial infarction, stroke, and any death | Incidence of composite endpoints of myocardial infarction, stroke, and any death at 6 months | 6 months |
| Incidence of composite endpoints of myocardial infarction, stroke, and any death | Incidence of composite endpoints of myocardial infarction, stroke, and any death at 12 months | 12 months |
| Surgical time | Surgical time | Through hospital stay,an average of 10 days |
| Hospitalization days | Hospitalization days | Through hospital stay,an average of 10 days |
| Hospitalization fees | Hospitalization fees | Through hospital stay,an average of 10 days |
| The first affiliated Hospital of Dalian Medical University | Not yet recruiting | Dalian | 116000 | China |
|
| Shanghai Changhai Hospital | Not yet recruiting | Shanghai | 200000 | China |
|
| Shanghai Changzheng Hospital | Recruiting | Shanghai | 200000 | China |
|
| Zhongshan Hospital affiliated to Fudan University | Recruiting | Shanghai | 200000 | China |
|
| The first affiliated Hospital of Xi ' an Jiaotong University | Recruiting | Xi'an | 710000 | China |
|