Paclitaxel-Coated Versus Uncoated Balloon for Treatment of Below-the-Knee In-Stent-Restenosis
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- primary patency of target lesion assessed by quantitative angiography
研究概览
简要总结
There is both a poor life expectancy and a poor prognosis of limb salvage in those patience with stenoses or occlusions of the lower limb. To date only a small number of these patients could be helped through medication or surgery. The indications for stent placement are poor primary results following percutaneous transluminal angioplasty or evidence of a flow-limiting dissection. The primary success rate after a stent placement is between 80% and 90%. One so far inconsistent discussed problem is the occurrence of in-stent restenosis which is expected in 20% to 78% of treated lesions, depending on the stent used. Using only percutaneous transluminal angioplasty for treatment of an in-stent restenosis, restenosis reoccurs in 70% to 80% of cases.
The aim of this study is to analyse the primary success and the long term results of angioplasty using the drug-coated balloon (paclitaxel) compared to an non-coated balloon in the treatment of in-stent restenosis of lower limb arteries.
详细描述
In this prospective, double-blind, randomised, multi-centre study the use of the already certified coated balloon and an uncoated balloon is evaluated in patients with in-stent restenoses/reocclusions of the lower limb artery. The whole lesion length should be covered by the balloon so that proximal and distal overlap of the lesion by a minimum of 5mm is assured. Based on the current literature the average restenoses rate of the lower limb arteries after percutaneous transluminal angioplasty of an in-stent restenosis is 70% after 6 months. Assuming the restenosis rate reduces to 30% after percutaneous transluminal angioplasty using a drug-coated balloon, with a significance level of Alpha=0.05 (bilateral) and a power Beta=0.8, the enrolment of 100 patients is required in order to show a significant difference between treatment groups, considering a dropout rate of 30%. The choice of treatment will be distributed in a randomised, double blind procedure.
The study duration per patient is 2 years. Clinical follow-up evaluations will take place after 3 and 6 months and after 1 and 2 years. After 3 month and 12 months an angiography of the target vessel will be performed.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age over 50 years
- •Signed declaration of consent
- •Subject is willing and able to participate in all the planned evaluations of the study protocol
- •Arterial occlusion disease stage 3 - 6 Rutherford-Becker
- •Subject with an in-stent stenosis over 70% of the vascular lumen diameter of the tibioperoneal trunc and/or the posterior tibial artery and/or of the anterior tibial artery and/or peroneal artery. Here vascular segments, which are affected continuous (including stent), proximal or distal of the stent by a relevant (re)stenosis, are treated according to randomisation
- •The length of the target lesion(s) should not exceed 290mm
- •In total four drug-coated balloons are enough to treat a maximum of two lesions
- •The target lesion's lumen diameter is between 2.0mm and 3.5mm
- •Successful passage of the wire to the target lesion before randomisation
排除标准
- •Coagulopathy
- •Pregnancy
- •Contraindications for antiplatelet or heparin
- •Factors which exclude a follow up
- •Life expectancy <12 months
- •Known allergies to contrast agents and/or Clopidogrel and/or Aspirin
- •>50% stenosis distal of the target lesion
- •Visible thrombus in the target lesion
- •Lytic therapy 72 hours before the planned intervention
- •Aneurysm of the femoral or popliteal artery
- •Intervention of focal lesions of the femoral or popliteal artery may be carried out before treatment of the target lesion in order to enhance the inflow in the lower limb
研究组 & 干预措施
Drug-coated balloon
- pre-dilatation of the target lesion with a non-coated balloon.
- treatment of the target lesion with the paclitaxel-coated balloon
干预措施: paclitaxel-coated balloon (Device)
non-coated balloon
Treatment of the target lesion with plain balloon angioplasty.
干预措施: non-coated balloon (Device)
结局指标
主要结局
primary patency of target lesion assessed by quantitative angiography
时间窗: 3 months after index procedure
次要结局
- Secondary patency of the target lesion assessed by quantitative angiography(12 months after index procedure)
研究者
Aljoscha Rastan
MD
Herz-Zentrums Bad Krozingen