Peripheral Arterial Disease, Superficial Femoral Artery Occlusion, Superficial Femoral Artery Stenosis
Conditions
Keywords
peripheral arterial disease, Drug eluting peripheral vascular stent system, primary patency
Brief summary
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.
Detailed description
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.
Interventions
DEVICEDrug eluting peripheral vascular stent system
Drug eluting peripheral vascular stent system、Color Doppler Ultrasonography (CDU) imaging、Dual Fluoroscopic Imaging、Digital subtraction angiography（DSA）
DEVICENitinol Stent System
Nitinol Stent System、Color Doppler Ultrasonography (CDU) imaging and Dual Fluoroscopic Imaging、Digital subtraction angiography（DSA）
Sponsors
Guangzhou Osmunda Medical Device Technology, Inc., Ltd.
Zhejiang Zylox Medical Device Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
in Preoperative: * Aged from 18 to 85 years old, male or female * Subject's target lesions were stenosis and/or occlusion * Subject is aware of the study content, showing sufficient compliance with the research protocol and sign the Informed Consent
Exclusion criteria
in Preoperative: * In-Stent Restenosis(IRS) or restenosis after drug-eluting balloon administration * Serum creatinine concentration of the subject is higher than 1.5 times of the upper limit of normal serum creatinine concentration * Subject with coagulation abnormalities should not be performed
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| primary patency rate at 12 months after operation | 12 months | the rate of the target lesion diameter stenosis \<50% patients confirmed by Color Doppler Ultrasonography (CDU) imaging at 12 months postoperatively |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| primary patency rate at 6 months after operation | 6 months | the rate of the target lesion diameter stenosis \<50% patients confirmed by Color Doppler Ultrasonography (CDU) imaging at 6 months postoperatively |
| target lesion revascularization rate | Preoperative，up to 1 month，6 months，12 months | 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 |
| Stent fracture rate | 6 months、12 months | using the Dual Fluoroscopic Imaging |
Countries
China
Contacts
Primary ContactGao Feng
Backup ContactLiang Jie
Outcome results
None listed