Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Guangzhou Osmunda Medical Device Technology, Inc., Ltd. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Evaluation of drug eluting peripheral vascular stent system for the treatment of superficial femoral artery stenosis and / or occlusion, there is better in effectiveness and clinical performance compared with similar products already on the market.
This is a prospective, multicenter, randomized study designed to enroll 138 patients with superficial femoral artery stenosis and /or occlusion who will be randomized 1:1 to be treated with the Drug eluting peripheral vascular stent system versus the commercially available Nitinol Stent System (Cordis Corporation). Patients will receive Color Doppler Ultrasonography (CDU) imaging and Dual Fluoroscopic Imaging at 6th month and 12th month post procedure. Clinical visits are scheduled at 0~30 days, 6 months, 12 months, and telephone visits are scheduled at 1 month, 3months, and 9 months. Furthermore, CDU will also be performed at baseline in all participants of the study.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | subjects using the drug eluting peripheral vascular stent system |
|
| Group B | Active Comparator | subjects using the Nitinol Stent System (Cordis Corporation) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Drug eluting peripheral vascular stent system | Device | Drug eluting peripheral vascular stent system、Color Doppler Ultrasonography (CDU) imaging、Dual Fluoroscopic Imaging、Digital subtraction angiography(DSA) |
| Measure | Description | Time Frame |
|---|---|---|
| primary patency rate at 12 months after operation | the rate of the target lesion diameter stenosis <50% patients confirmed by Color Doppler Ultrasonography (CDU) imaging at 12 months postoperatively | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| primary patency rate at 6 months after operation | the rate of the target lesion diameter stenosis <50% patients confirmed by Color Doppler Ultrasonography (CDU) imaging at 6 months postoperatively | 6 months |
| target lesion revascularization rate |
Not provided
Inclusion Criteria in Preoperative:
Exclusion Criteria in Preoperative:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gao Feng | Contact | +86 (0)10 8220-7036 | 823 | md@osmundacn.com |
| Liang Jie | Contact | 13819565660 | jie.liang@zyloxmedical.com |
| Name | Affiliation | Role |
|---|---|---|
| Chen Zhong | Beijing Anzhen Hospital | Principal Investigator |
| Guo Wei | Chinese PLA General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West China Hospital, Sichuan University | Recruiting | Chengdu | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Nitinol Stent System | Device | Nitinol Stent System、Color Doppler Ultrasonography (CDU) imaging and Dual Fluoroscopic Imaging、Digital subtraction angiography(DSA) |
|
|
subject found that the presence of restenosis in the target lesion in follow-up , and need to re-intervention or bypass graft according to the clinical symptoms
| Preoperative,up to 1 month,6 months,12 months |
| Stent fracture rate | using the Dual Fluoroscopic Imaging | 6 months、12 months |
| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
Not provided
Not provided