Peripheral Vascular Disease Clinical Trial
Official title:
Percutaneous Transluminal Balloon Angioplasty (PTA) and Drug Eluting Stents for Infrapopliteal Lesions in Critical Limb Ischemia
The purpose of this study is to investigate the performance of paclitaxel-coated balloon expandable stainless steel coronary stent for the treatment of infrapopliteal stenoses and occlusions in patients with critical limb ischemia compared to percutaneous transluminal balloon angioplasty (PTA).
Critical limb ischemia (CLI) is a serious condition that is becoming more and more common in
the western world due to the growing percentage of elderly in the population and the rising
incidence of diabetes. In about 40% of patients a stenosis or occlusion in the arteries below
the level of the knee will be present. Restoration of blood flow is imperative to allow pain
relief and tissue healing. Without revascularization patients with CLI are at risk for limb
loss and potentially fatal complications such as sepsis.
In patients treated with percutaneous transluminal balloon angioplasty (PTA)significant
restenosis is found in approximately 50% after 6 months.
In interventional cardiology a significant reduction in restenosis rates in coronary arteries
has been found using drug eluting stents (DES), including the paclitaxel eluting stent
(TAXUS, Boston Scientific). DES locally deliver drugs (e.g. paclitaxel) that interfere with
the restenosis process.
Using DES in treating below the knee (infrapopliteal) arterial lesions in patients with CLI
may improve patency and clinical outcome.
Comparison:
Treatment of below the knee arterial lesions in patients with CLI with PTA and DES compared
to only PTA.
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