Stenting of the Superficial Femoral and/or Proximal Popliteal Artery Project With Boston Scientific's Innova Drug Eluting Stent
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 15
- 主要终点
- Primary Patency
研究概览
简要总结
To determine whether the Boston Scientific nitinol drug-eluting stent shows acceptable performance at 9 months when treating Superficial Femoral (SFA) and/or Proximal Popliteal Artery (PPA) lesions.
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
- •Subjects age 18 and older
- •Subject (or Legal Guardian if applicable) has signed the consent form and is willing and able to provide consent before any study-specific tests or procedures are performed and agrees to attend all required follow-up visits
- •Chronic, symptomatic lower limb ischemia defined as Rutherford categories 2, 3 or 4
- •Stenotic, restenotic (from angioplasty only, previous treatment with drug coated balloon is not allowed) or occlusive lesion(s) located in the native superficial femoral artery or proximal popliteal artery:
- •Degree of stenosis ≥70% by visual angiographic assessment
- •Vessel diameter ≥ 4 and ≤ 6mm
- •Total lesion length (or series of lesions) ≥30 mm and ≤110 mm
- •(Note: tandem lesions may be treated, provided that the tandem lesion segment can be covered with only one stent)
- •Target lesion located at least three centimeters above the inferior edge of the femur
- •Patent infrapopliteal and popliteal artery, i.e., single vessel runoff or better with at least one of three vessels patent (<50% stenosis) to the ankle or foot
排除标准
- 未提供
研究组 & 干预措施
Test device arm (DES SFA)
Patients in this arm will receive the study device: the Boston Scientific DES SFA Paclitaxel-Eluting Self-Expanding Stent System (DES SFA)
干预措施: The Boston Scientific DES SFA Paclitaxel-Eluting Self-Expanding Stent System (DES SFA) (Device)
结局指标
主要结局
Primary Patency
时间窗: 9-months
Primary patency of target lesion at 9-months assessed by duplex ultrasound (DUS) as adjudicated by an independent core laboratory. Primary Patency: percentage (%) of lesions (target stented segments) that reach endpoint without a hemodynamically significant stenosis on DUS and without target lesion revascularization (TLR) or, bypass of the target lesion.
次要结局
未报告次要终点