Paclitaxel-Coated Versus Uncoated Balloon for Treatment of Below-the-Knee In-Stent-Restenosis (BAIR)

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.

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.

• Device: paclitaxel-coated balloon
  Balloon is coated with paclitaxel in a concentration of 3µg/mm2.
• Device: non-coated balloon
  percutaneous transluminal angioplasty with a non-coated balloon

• Active Comparator: Drug-coated balloon
  1. pre-dilatation of the target lesion with a non-coated balloon.
  2. treatment of the target lesion with the paclitaxel-coated balloon
  Intervention: Device: paclitaxel-coated balloon
• Placebo Comparator: non-coated balloon
  Treatment of the target lesion with plain balloon angioplasty.
  Intervention: Device: non-coated balloon

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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