Peripheral Arterial Disease Clinical Trial
Official title:
The Safety and Efficacy of Drug Eluting Peripheral Vascular Stent System for the Treatment of Superficial Femoral Artery Stenosis and /or Occlusion: a Multi-center Stratified Randomized Single- Blind Controlled Trial
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.
Status | Recruiting |
Enrollment | 138 |
Est. completion date | February 2021 |
Est. primary completion date | July 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
China | West China Hospital, Sichuan University | Chengdu |
Lead Sponsor | Collaborator |
---|---|
Zhejiang Zylox Medical Device Co., Ltd. | Guangzhou Osmunda Medical Device Technology, Inc., Ltd. |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Secondary | 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 | |
Secondary | target lesion revascularization rate | 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 | |
Secondary | Stent fracture rate | using the Dual Fluoroscopic Imaging | 6 months?12 months |
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