150
Participants
Start Date
November 30, 2006
Primary Completion Date
March 31, 2011
Study Completion Date
April 30, 2012
iloprost
"The study, consists of two substudies, which deal with patients susceptible to medical therapy alone (substudy 1) or treated with classical surgical therapy (substudy 2).~For each substudy, pts will be divided into two groups, one that will receive conventional treatments but not prostanoids, other conventional treatments with addition of iloprost.~The 4 groups:~1A. Pts unsuitable to surgical or endovascular vascular therapy: conventional treatment~1. B. Pts unsuitable to surgical or endovascular vascular therapy: treatment with iloprost plus conventional treatment~2. A. Pts suitable to vascular surgical or endovascular therapy: conventional treatment~2B. Pts suitable to vascular surgical or endovascular therapy: treatment with iloprost plus conventional treatment"
Standard Treatment (aspirin.....),
"The standard treatment, as has already been explained in the submission is the best treatment that the guidelines suggest for that specific type of patient with those complications and with stage 2b severe PAD.~correction of concomitant risk factors, physical exercise, antiplatelet, standard heparin /low molecular weight heparin, hemorheological/vasodilators such as pentoxifylline/buflomedil, propionyl-L-carnitine, Defibrotide) but not prostanoids"
"Vascular Surgery, Hospital Galliera", Genoa
Internal Medicine, Hospital Civile, Legnano
"Internal Medicine, Hospital Fondazione Circolo Macchi", Varese
Internal Medicine, Hospital of Fermo, Fermo
"Internal Medicine, Hospital Policlinico", Bari
"Internal Medicine, Madonna delle Grazie Hospital", Matera
"Internal Medicine, Hospital Fatebenefratelli", Naples
"Surgery Dept., Hospital San Giovanni Bosco", Naples
"Angiology, Hospital G. Fucito", Mercato San Severino
"Internal Medicine, Hospital Pugliese - Ciaccio", Catanzaro
"Internal Medicine, Hospital Bianchi Melacrino Morelli", Reggio Calabria
"Internal Medicine, Hospital Jazzolino", Vibo Valentia
"Angiology, Hospital Ferrarotto - Alessi", Catania
Internal Medicine, Hospital Policlinico Campus Biomedico, Rome
Fadoi Foundation, Italy
OTHER