NCT02430922已完成2 期
EVOLUTION STUDY, a Physician-inititated Trial Investigating the Efficacy of the Self-Expanding iVolution Nitinol Stent for Treatment of Femoropopliteal Lesions
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 8
- 主要终点
- Primary Patency at 12 months
研究概览
简要总结
The objective of this clinical investigation is to evaluate the short-term (up to 12 months) outcome of treatment by means of the self-expanding iVolution nitinol stent in symptomatic (Rutherford 2-4) femoropopliteal arterial stenotic or occlusive 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
- •De novo lesion located in the femoropopliteal arteries suitable for endovascular treatment
- •Patient presenting with a score from 2 to 4 according to the Rutherford classification
- •Patient is willing and able to comply with specified follow-up evaluations at the predefined time intervals
- •Patient is >18 years old
- •Patient understands the nature of the procedure and provides written informed consent, prior to enrollment in the study
- •Prior to enrollment, the target lesion was crossed with standard guidewire manipulation One target lesion is located within the native SFA: distal point 3 cm above knee joint
- •The target lesion has angiographic evidence of stenosis or occlusion
- •Length of the target lesion is ≤ 15 cm by visual estimation
- •Target vessel diameter visually estimated is ≥4 mm and ≤7 mm
- •There is angiographic evidence of at least one vessel-runoff to the foot
排除标准
- •Presence of a stent in the target vessel that was placed during a previous procedure
- •Presence of an aortic thrombosis or significant common femoral ipsilateral stenosis
- •Previous bypass surgery in the same limb
- •Patients contraindicated for antiplatelet therapy, anticoagulants or thrombolytics
- •Patients who exhibit persistent acute intraluminal thrombus at the target lesion site
- •Perforation at the angioplasty site evidenced by extravasation of contrast medium
- •Patients with known hypersensitivity to nickel-titanium or other study device components
- •Patients with uncorrected bleeding disorders
- •Female patient with child bearing potential not taking adequate contraceptives or currently breastfeeding
- •Life expectancy of less than 12 months
- •Ipsilateral iliac artery treatment before target lesion treatment with a residual stenosis > 30%
- •Use of thrombectomy, atherectomy 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 reached the primary endpoint
研究组 & 干预措施
iVolution stent
Experimental
Patient's treated with the iVolution stent from iVascular for the treatment of femoropopliteal lesions.
干预措施: iVolution nitinol stent (Device)
结局指标
主要结局
Primary Patency at 12 months
时间窗: 12 months
freedom from \>50% restenosis at 12 months as indicated by an independently verified duplex ultrasound peak systolic velocity ratio (PSVR) \<2.5 in the target vessel with no reintervention
次要结局
- Primary Patency at 1 & 6 months(1 & 6 months)
- Technical Success(Procedure)
- Freedom from Target Lesion Revascularization (TLR) at 1, 6 and 12 months(at all follow-up visits)
- Serious adverse events until follow-up completions(1,6,12 months and interem visits)
- Clinical Success at 1, 6 and 12 months(at all follow-up visits)
研究者
研究点 (8)
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