Randomized Trial Comparing Drug Eluting Stent Zilver PTX vs Bare Metal Stent Zilver Flex in Critical Limb Ischemia and Treatment of Lesions in Femoral and Popliteal Arteries"
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 49
- 主要终点
- Freedom from TLR (Target Lesion Revascularization)
研究概览
简要总结
Randomized study comparing the results between drug-eluting stents and standard bare metal stents, when treating femoropopliteal lesions in patients with critical limb ischemia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Critical limb ischemia RC 4-6
- •Lesions in superficial femoral artery and popliteal artery (p1 -p2)
- •Target vessel 4-8mm
- •At least I 1 vessel runoff to the foot
- •Age >18 years
排除标准
- •Patient disapproval
- •Age <18 years
研究组 & 干预措施
Drug Eluting Stent (DES)
Drug Eluting Stent (DES). Zilver PTX.
干预措施: Treatment with Zilver PTX Drug Eluting Stent (DES) in femoropopliteal lesions (Device)
Bare Metal Stent (BMS)
Bare Metal Stent (BMS). Zilver Flex
干预措施: Treatment with Zilver Flex Bare Metal Stent (BMS) in femoropopliteal lesions (Device)
结局指标
主要结局
Freedom from TLR (Target Lesion Revascularization)
时间窗: 24 months
Fraction of study subjects without need for retreatment at treatment location
Open (functioning and not stenosed) vascular reconstruction (Primary Patency)
时间窗: 24 months
Functioning revascularization without adjunctive measures
Event Free Survival
时间窗: 24 months
Alive without vascular events
Freedom from TLR (Target Lesion Revascularization)
时间窗: 6 months
Fraction of study subjects without need for retreatment at treatment location
Freedom from TLR (Target Lesion Revascularization)
时间窗: 12 months
Fraction of study subjects without need for retreatment at treatment location
Open (functioning and not stenosed) vascular reconstruction (Primary Patency)
时间窗: 12months
Functioning revascularization without adjunctive measures
次要结局
未报告次要终点
研究者
Torbjorn Fransson
Principal Investigator, Consultant Vascular Surgeon
Skane University Hospital