NCT01221610已完成不适用
A Prospective, Multi-centre, Randomized Controlled, First in Man Study to Assess the Safety and Performance of the Passeo-18 Lux Paclitaxel Releasing PTA Balloon Catheter vs. the Uncoated Passeo 18 Balloon Catheter in Patients With Stenosis and Occlusion of the Femoropopliteal Arteries (BIOLUX P-I).
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Biotronik AG
- 入组人数
- 60
- 试验地点
- 5
- 主要终点
- Assessment of the 6 months late lumen loss in the target lesion measured by quantitative vascular angiography (QVA).
研究概览
简要总结
A prospective, multi-centre, randomized controlled, First in Man study to assess the safety and performance of the coated Passeo-18 Lux Paclitaxel releasing PTA Balloon Catheter vs. an uncoated balloon catheter in patients with stenosis and occlusion of the femoropopliteal arteries.
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
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 50 years,
- •Informed consent signed by patient prior to randomization
- •Single or sequential de novo or restenotic lesions (stenosis ≥ 70% diameter reduction or occlusion) in the femoropopliteal arteries ≥ 30 mm and ≤ 200 mm long
- •Rutherford Class 2 - 5 in the target limb
- •Reference Vessel Diameter (RVD) 3 - 7 mm, based on visual estimation
- •Inflow free from flow-limiting lesion (< 50% stenosis) confirmed by angiography. Patients with flow-limiting inflow lesions (> 50% stenosis) can be included if lesion has been treated successfully before the index procedure
- •At least one non-occluded crural vessel (eg without significant stenosis) with angiographically documented run-off to the foot
- •Successful wire crossing of the lesion
- •Willingness to comply with all specified follow-up evaluations
- •Male or negative pregnancy test of women in childbearing age
排除标准
- •Co-morbid conditions limiting life expectancy ≤ 1 year
- •Patient currently participating in another clinical trial
- •Lesions which are untreatable with PTA or other interventional techniques
- •The target stenosis is located distal to a stenosis ≥ 50% that cannot be pre-treated because the drug coating could get lost during crossing the proximal lesion
- •Thrombus in the target vessel, documented by angiography
- •Target lesion is severely calcified, documented by angiography
- •Prior bypass surgery of target vessel
- •Previously implanted stent in the target lesion
- •Treatment of bifurcation required
- •Planned amputation of the target limb
- •Flow-limiting (> 50% DS) Inflow lesion proximal to target lesion, left untreated
- •Failure to obtain <30% residual stenosis in a pre-existing haemodynamically significant (>50% DS) inflow lesion in the ipsilateral iliac or proximal SFA. (DEB or DES not allowed for the treatment of inflow lesion)
- •Additional hemodynamically relevant proximal and distal lesions with stenosis ≥ 50 %, except iliac arteries, are excluded. Iliac artery lesion treatments have to be successful with a residual stenosis ≤ 30 %
- •Haemorrhagic diathesis or another disorder such as gastrointestinal ulceration or cerebral circulatory disorders which restrict the use of platelet aggregation inhibitor therapy and anticoagulation therapy
- •Phenprocoumon intake
- •Impaired renal function (creatinine ≥ 2.0 - 2.5 mg/dl), according to investigator assessment
- •Known allergy to contrast media that cannot be adequately controlled with pre-medication
- •Allergy, intolerance or hypersensitivity to Paclitaxel structurally or related compounds and/or to the delivery matrix n-Butyryl tri-nhexyl citrate (BTHC)
结局指标
主要结局
Assessment of the 6 months late lumen loss in the target lesion measured by quantitative vascular angiography (QVA).
时间窗: 6 months
次要结局
- 6 months and 12 months TLR rate(6 and 12 months)
- 6 months and 12 months change in Rutherford class(6 and 12 months)
- Major Adverse Event rate at 6 and 12 months (procedure- or device-related death or amputation, target lesion thrombosis and clinically driven TLR)(6 and 12 months)
- 6 months binary restenosis rate(6 months)
- 6 months and 12 months change in mean ABI(6 and 12 months)
研究者
研究点 (5)
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