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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Paclitaxel-Coated Versus Uncoated Balloon for Treatment of Below-the-Knee In-Stent-Restenosis

Conditions
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In-stent Stenosis of Infrapopliteal Arteries

Intervention / Treatment
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* Device: paclitaxel-coated balloon
* Device: non-coated balloon


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Drug-coated balloon<br>pre-dilatation of the target lesion with a non-coated balloon. treatment of the target lesion with the paclitaxel-coated balloon | Device: paclitaxel-coated balloon<br>* Balloon is coated with paclitaxel in a concentration of 3µg/mm2.<br>|
| Placebo Comparator: non-coated balloon<br>Treatment of the target lesion with plain balloon angioplasty. | Device: non-coated balloon<br>* percutaneous transluminal angioplasty with a non-coated balloon<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| primary patency of target lesion assessed by quantitative angiography |  | 3 months after index procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary patency of the target lesion assessed by quantitative angiography |  | 12 months after index procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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infrapopliteal arteries, In-stent stenosis, long lesions, drug-coated balloon