NCT01412463已完成4 期
DURABILITY+ : a Prospective, Multi-center, Controlled Study Measuring the Durability in Lesions of the Superficial Femoral Artery of the Protégé Everflex+ Stent
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 6
- 主要终点
- Primary stent patency
研究概览
简要总结
The objective of this study is to evaluate the immediate and long-term (up to 12 months) safety and effectiveness of primary stenting with the Protégé Everflex+ stent system for the treatment of superficial femoral artery (SFA) lesions (without involvement of the popliteal artery) between 40 mm and 180 mm in length.
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
- •De novo, restenotic or reoccluded (from PTA or adjunct therapy, not including stents or stent grafts) lesion located in the superficial femoral artery (without popliteal involvement) with proximal point at least one centimeter below the origin of the profunda femoralis and suitable for stenting
- •Patient presenting with a score from 2 to 4 following Rutherford classification
- •Patient is willing to comply with specified follow-up evaluations at the specified times
- •Patient is >18 years old
- •Patient (or their legal representative) understands the nature of the procedure and provides written informed consent, prior to enrollment in the study
- •Angiographic Inclusion Criteria
- •The length of the target lesion is minimally 40 mm and maximally 180 mm, to be covered with one stent
- •The target lesion has angiographic evidence of stenosis or restenosis > 50% or occlusion which can be passed with standard guidewire manipulation
- •Target vessel diameter visually estimated is >3.5 mm and <7.5 mm
- •Prior to enrollment, the guidewire has crossed target lesion
- •There is angiographic evidence of at least one-vessel-runoff to the foot, irrespective of whether or not outflow was re-established by means of previous endovascular intervention
- •Patient is eligible for treatment with the Protégé Everflex+ stent system
排除标准
- •Presence of another stent or stent graft in the target vessel that was placed during a previous procedure
- •Previous by-pass surgery in the same limb requiring access to the target lesion
- •Patients for whom antiplatelet therapy, anticoagulants or thrombolytic drugs are contraindicated or no alternative is available
- •Patients with known hypersensitivity to nickel-titanium
- •Patients with uncorrected bleeding disorders
- •Female patient with child bearing potential not using adequate contraceptives or currently breastfeeding
- •Life expectancy of less than twelve months
- •Use of thrombectomy, artherectomy, cryoplasty, cutting balloon, drug-eluting balloon, embolic protection or laser devices during procedure
- •Any patient considered to be hemodynamically unstable at onset of procedure
- •Patient is currently participating in another investigational drug or device study that has not completed the entire follow up period.
- •Angiographic Exclusion Criteria
- •Presence of an aortic thrombosis or significant common femoral ipsilateral stenosis
- •Patients who exhibit persistent acute intraluminal thrombus of the proposed target lesion site
- •Perforation, dissection or other injury of the access site or target vessel requiring additional stenting or surgical intervention prior to start of the index procedure
- •Perforation at the angioplasty site evidenced by extravasation of contrast medium
- •Aneurysm located at the level of the SFA and/or proximal popliteal
结局指标
主要结局
Primary stent patency
时间窗: 12 months post-procedure
The primary effectiveness endpoint of the study is primary stent patency at 12 months. Primary patency is defined as absence of a hemodynamically significant stenosis on duplex ultrasound (systolic velocity ratio no greater than 2.4) at the target lesion and without TLR within 12 months.
Major Adverse Event rate
时间窗: 30 days post-procedure
The primary safety endpoint of the study is the Major Adverse Event (MAE) rate at 30 days. MAE is defined as: clinically-driven target lesion revascularization, amputation of treated limb or all-cause mortality through 30 days post procedure.
次要结局
- Primary stent patency at 1 and 6 months(1 and 6 months post-procedure)
- Target lesion revascularization(12 months post-procedure)
- limb-salvage(12-months post-procedure)
- Serious adverse events(12-months post-procedure)
- Technical success(1 day post-procedure)
- Primary assisted patency(1, 6 and 12 months post-procedure)
- Secondary patency(1, 6 and 12 months post-procedure)
- Clinical success(1, 6 and 12 months post-procedure)
研究者
研究点 (6)
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