NCT02678065Unknown4 期
In.Pact Flexion, a Physician Initiated Trial Investigating the Performance of the In.Pact Admiral Drug-eluting Balloon for the Treatment of Popliteal Lesions
适应症
干预措施
试验速览
- 阶段
- 4 期
- 入组人数
- 100
- 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 study is to evaluate the performance of the In.Pact Admiral DEB for the treatment of popliteal lesions in comparison with literature results of stent treatment in popliteal 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, restenotic or reoccluded lesion located in the popliteal artery, with or without superficial femoral artery involvement
- •Patient presenting a score from 2 to 5 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 enrolment in the study
- •Prior to enrollment, the guidewire has crossed target lesion
- •Patient is eligible for treatment with the In.Pact Admiral drug-eluting balloon
- •The target lesion, visually estimated, has a maximal length of 14 cm and can be categorized as either a type A or B lesion according the TASC II guidelines
- •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 >3.5mm and <7.5 mm
- •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.
排除标准
- •- Presence of another stent in the target vessel that was placed during a previous procedure
- •Presence of an aortic thrombosis or significant common femoral ipsilateral stenosis
- •Previous by-pass surgery in the same limb
- •Patients for whom antiplatelet therapy, anticoagulants or thrombolytic drugs are contraindicated
- •Patients who exhibit persistent acute intraluminal thrombus of the proposed lesion site
- •Perforation at the angioplasty site evidenced by extravasation of contrast medium
- •Patients with known hypersensitivity to nickel-titanium
- •Patients with uncorrected bleeding disorders
- •Aneurysm located at the level of the SFA and/or popliteal artery
- •Female patient with child bearing potential not taking adequate contraceptives or currently breastfeeding
- •Life expectancy of less than twelve months
- •Ipsilateral iliac treatment before the target lesion procedure with a residual stenosis > 30% or ipsilateral iliac treatment conducted after the target lesion procedure
- •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 completed the entire follow up period.
研究组 & 干预措施
InPact Admiral
Experimental
Patients treated with the InPact Admiral balloon for popliteal lesions
干预措施: InPact Admiral DEB (Device)
结局指标
主要结局
Primary Patency at 12 months
时间窗: 12 months
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.
次要结局
- Technical success(1 day post-op)
- Primary Patency at 1 and 6-months(1 and 6 months)
- Clinical success at 1, 6 and 12-months(1, 6 and 12 months)
- Serious Adverse Events(up to 12 months)
- Survival rate(up to 12 months)
- Target Lesion Revascularization(up to 12 months)
- Limb Salvage Rate(up to 12 months)
研究者
研究点 (8)
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