A Phase 3 interventional study of paclitaxel-coated balloon and non-coated balloon in In-stent Stenosis of Infrapopliteal Arteries, sponsored by Herz-Zentrums Bad Krozingen. Withdrawn at 1 site in Germany. Open to participants aged 50 Years to 90 Years. Per ClinicalTrials.gov, last updated 2015-08-05.
Sponsored by Herz-Zentrums Bad Krozingen · Phase 3, Interventional, and Treatment
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.
1,117 studies on the registry are indexed under Constriction, Pathologic; 231 are open to participants now.
Browse Constriction, Pathologic studies →Herz-Zentrums Bad Krozingen is the lead sponsor of 7 studies on the registry; none are open to participants now.
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Exclusion Criteria:
1. pre-dilatation of the target lesion with a non-coated balloon. 2. treatment of the target lesion with the paclitaxel-coated balloon
Device: paclitaxel-coated balloon
Treatment of the target lesion with plain balloon angioplasty.
Device: non-coated balloon
Balloon is coated with paclitaxel in a concentration of 3µg/mm2.
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
This study is withdrawn, as verified in Aug 2015. You cannot join it, but the record below documents what was studied.
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Herz-Zentrums Bad Krozingen