The purpose of the PADI trial was to assess the performance of paclitaxel‐eluting DESs compared with PTA‐BMS in infrapopliteal lesions causing CLI. Patients were enrolled between October 2007 and February 2013 at 3 major vascular centers in the Netherlands. The study protocol was approved by the medical ethics boards of the participating centers, and all enrolled patients gave written informed consent. Adults with a Rutherford category15 ≥4 due to infrapopliteal lesions, as assessed with pretreatment imaging, were randomly allocated to one of the 2 treatment arms. Randomization was per limb. When a patient was included for both limbs, each limb was randomized separately. A maximum of 3 lesions per limb could be included, with each of these lesions allocated to the same treatment arm. In the DES arm, target lesions were treated with paclitaxel‐eluting stainless steel coronary stents (TAXUS Liberté; Boston Scientific). Patients in the PTA‐BMS arm received PTA with optional bailout stenting using non–drug‐eluting BMS. All patients were treated with carbasalate calcium (100 mg daily, indefinitely) and clopidogrel (loading dose of 300 mg directly after the procedure followed by 75 mg daily for at least 6 months). Details of the study design and short‐ and midterm results have been reported previously.12 , 14 The trial was registered at ClinicalTrials.gov (identifier NCT00471289).
Taxus libert
Manufactured by Boston Scientific
Sourced in United States
The TAXUS Liberté is a drug-eluting stent system designed for the treatment of coronary artery disease. It consists of a metal stent coated with the drug paclitaxel, which is intended to help prevent the recurrence of narrowing in the treated artery.
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Lab products found in correlation
3 protocols using taxus libert
1
PADI Trial: Paclitaxel-Eluting DES vs. PTA-BMS
2
Randomized Paclitaxel-Eluting Stent Trial
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After crossing the SVG lesion with a guidewire, eligible patients were randomly assigned in a 1:1 ratio to receive either the paclitaxel‐eluting TAXUS Liberté (DES group) or the bare‐metal Liberté stent (BMS group; both manufactured by Boston Scientific Corporation, Natick, MA). In each participating center, the 1:1 allocation to treatment arms was made by means of an internet‐based system using computer‐generated simple randomization via a secure website accessible by password only. Time of randomization was defined as time zero.
3
Stenosis Treatment with Stent Implantation
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Patients with stenosis diagnosed using Doppler ultrasonography underwent an angiographic study. The access route for the procedures was either the ipsilateral or contralateral common femoral artery. Pelvic and transplanted renal artery angiograms were performed for anatomical evaluation and lesion quantification.
Following angiographic confirmation of stenosis, systemic heparinization was performed with unfractionated heparin, followed by transposition of the lesion with a 0.014 guidewire. All cases were treated with stent implantation: in one case, a self-expanding stent was used, and in the other cases, expandable balloon stents, such as Vision® Cobalt Chromium (Abbott Laboratories, Chicago, IL, USA), TAXUS™ Liberté™ (Boston Scientific Corporation, Natick, MA, USA), Express™ Vascular Stent (Boston Scientific Corporation), Dynamic Stent (BIOTRONIK, Berlin, Germany), and/or Direct-Stent® (InSitu Technologies, St. Paul, MN, USA), were used. The materials were used without standardization at the discretion of the interventional physician. At the end of the procedure, hemostatic devices, such as the Perclose Proglide (Abbott) and/or the StarClose (Abbott) devices, were used at the puncture site.
Following angiographic confirmation of stenosis, systemic heparinization was performed with unfractionated heparin, followed by transposition of the lesion with a 0.014 guidewire. All cases were treated with stent implantation: in one case, a self-expanding stent was used, and in the other cases, expandable balloon stents, such as Vision® Cobalt Chromium (Abbott Laboratories, Chicago, IL, USA), TAXUS™ Liberté™ (Boston Scientific Corporation, Natick, MA, USA), Express™ Vascular Stent (Boston Scientific Corporation), Dynamic Stent (BIOTRONIK, Berlin, Germany), and/or Direct-Stent® (InSitu Technologies, St. Paul, MN, USA), were used. The materials were used without standardization at the discretion of the interventional physician. At the end of the procedure, hemostatic devices, such as the Perclose Proglide (Abbott) and/or the StarClose (Abbott) devices, were used at the puncture site.
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