Paclitaxel-Coated Versus Uncoated Balloon for Treatment of Below-the-Knee In-Stent-Restenosis (BAIR)
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|ClinicalTrials.gov Identifier: NCT01398033|
Recruitment Status : Withdrawn (Study stopped due to lack of patient inclusion)
First Posted : July 20, 2011
Last Update Posted : August 5, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|In-stent Stenosis of Infrapopliteal Arteries||Device: paclitaxel-coated balloon Device: non-coated balloon||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Paclitaxel-Coated Versus Uncoated Balloon for Treatment of Below-the-Knee In-Stent-Restenosis|
|Study Start Date :||April 2012|
|Estimated Primary Completion Date :||September 2013|
|Estimated Study Completion Date :||September 2014|
Active Comparator: Drug-coated balloon
Device: paclitaxel-coated balloon
Balloon is coated with paclitaxel in a concentration of 3µg/mm2.
Placebo Comparator: non-coated balloon
Treatment of the target lesion with plain balloon angioplasty.
Device: non-coated balloon
percutaneous transluminal angioplasty with a non-coated balloon
- primary patency of target lesion assessed by quantitative angiography [ Time Frame: 3 months after index procedure ]
- Secondary patency of the target lesion assessed by quantitative angiography [ Time Frame: 12 months after index procedure ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01398033
|Herzzentrum Bad Krozingen|
|Bad Krozingen, Germany, 79219|
|Principal Investigator:||Aljoscha Rastan, M.D.||Herzzentrum Bad Krozingen|