Does Local Paclitaxel Improve the Efficacy of Balloon Angioplasty Without Stent Implantation for Treatment of Below the Knee Artery Lesions?
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 120
- 试验地点
- 7
- 主要终点
- Occlusion rate of the target lesion at 6 months
研究概览
简要总结
Patients with claudication or critical limb ischemia will be treated either with uncoated balloons or paclitaxel coated balloons in order to enhance the vessel patency in stenosed or occluded below the knee arteries
详细描述
After successful guide wire passage of the below the knee index lesions the patients will either receive a treatment with a conventional uncoated balloon or a balloon coated with paclitaxel. Only patients who require follow-up angiography after 6 months will be included in this study. The primary endpoint (index vessel occluded or still open) is at 6 months - the patients will be also followed for 24 months for clinical endpoints. In addition an MRI is planned at 12 months.
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
- Single (Participant)
盲法说明
drug coated balloon versus uncoated balloon
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
- •>18 years of age
- •Chronic stenotic or occlusive atherosclerotic disease of the infrapopliteal arteries
- •Rutherford 2-5 patients
- •Patients with ≤ 2 BTK lesions (≥ 70% diameter stenosis)
- •Lesion length limited to 5-25 cm
排除标准
- •Planned or foreseeable amputation
- •Previous amputation at the index limb
- •Index vessel with no run-off to the foot distal to the index lesion
- •Prior treatment of the index lesion with a drug coated balloon
- •In-stent restenosis
- •Life expectancy <1 year
- •Known creatinine >1.4 mg% if patient is not on dialysis
- •Acute thrombus in the index limb
- •Aneurysm in the index leg
- •Known hypersensitivity or contraindication to aspirin, heparin, clopidogrel, abciximab, paclitaxel
- •Patients with concomitant medical illnesses that require cytostatic or radiation therapy
研究组 & 干预措施
Drug coated balloon
SeQuentPlease OTW paclitaxel coated balloon catheter
干预措施: SequentPlease OTW paclitaxel coated balloon catheter (Device)
uncoated PTA balloon catheter
Standard of care uncoated BTK balloon catheter
干预措施: conventional uncoated balloon for BTK endovascular therapy (Device)
结局指标
主要结局
Occlusion rate of the target lesion at 6 months
时间窗: 6 +/- 1 months
by digital substraction angiogram or MRI
次要结局
- target lesion revascularization(3, 6, 12 and 24 months)
研究者
Prof. Dr. med. Gunnar Tepe
Director of the Deparment of Radiology, Clinical Professor
Klinikum Rosenheim