NCT00827619已完成不适用
Evaluation of the Zilver® Flex™ Vascular Stent in the Above-the-Knee Femoropopliteal Artery
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 3
- 主要终点
- Primary patency of the treated lesion within the superficial femoral artery
研究概览
简要总结
This study is intended to evaluate the long-term effectiveness of treatment of de novo or restenotic lesions of the above-the-knee femoropopliteal artery using the Zilver® Flex™ Vascular Stent which has received the CE mark for commercial use. The study is designed as a single arm non-randomized post-approval study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are at least 18 years old and have at least 1 stenotic atherosclerotic lesion of the above-the-knee femoropopliteal artery may be considered for enrollment.
- •To be enrolled in the study, the lesion must be the appropriate size and and no prior stent in the target vessel may be present.
排除标准
- •Patient is < 18 years of age.
- •Patient is pregnant or breast-feeding.
- •Patient is simultaneously participating in an investigational drug or device study. The patient must have completed the follow-up phase for the primary endpoint of any previous study at least 30 days prior to enrollment in this study.
- •Patient has had previous stenting of the target vessel.
- •Patient has a medical condition or disorder that would limit life expectancy to less than 1 year or that may cause noncompliance with the protocol or confound the data analysis.
- •Patient in whom antiplatelet and/or anticoagulant therapy is contraindicated.
- •Patient has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions.
- •Patient has known hypersensitivity or contraindication to aspirin, antiplatelet medication, contrast dye, or nitinol that, in the opinion of the investigator, cannot be adequately premedicated.
研究组 & 干预措施
1
Other
single arm non-randomized post-market study
干预措施: Zilver® Flex™ Vascular Stent (Device)
结局指标
主要结局
Primary patency of the treated lesion within the superficial femoral artery
时间窗: 1 year after patient enrollment
次要结局
- Procedural success and primary-assisted and secondary patency, thrombosis/total occlusion rate, clinical improvement, and functional status improvement(1 year after patient enrollment)
研究者
研究点 (3)
Loading locations...
相似试验
已完成
不适用
Evaluation of Safety and Efficacy of the FlexStent® Femoropopliteal Self-Expanding Stent SystemPeripheral Artery DiseaseVascular DiseaseCardiovascular DiseasesPADPeripheral Vascular DiseaseNCT01355406Cordis Corporation257
已完成
2 期
Evaluation of the Zilver Vascular Stent in the Iliac Arteries (ZIPS)Peripheral Arterial Disease (PAD)NCT00196066Cook Group Incorporated150
已完成
不适用
Evaluation of the Zilver PTX Drug-Eluting Stent in the Above-the-Knee Femoropopliteal ArteryPeripheral Vascular DiseasesNCT00120406Cook Group Incorporated474
招募中
不适用
Smart Flex Stent System for the Treatment Long Femoropopliteal Artery LesionsPeripheral Arterial DiseaseNCT05894863RenJi Hospital120
Unknown
不适用
Restenosis Intrastent: Treatment of Bioresorbable Vascular Scaffolds RestenosisCoronary In-stnent RestenosisNCT03167424Spanish Society of Cardiology100