DESIGN: Prospective, randomised single-centre pilot study comparing a beta with a gamma source and a sirolimus-eluting stent in patients with an estimated high risk of restenosis (40 to 50%). PURPOSE: Although the majority of patients referred for revascularisation are now being treated with percutaneous coronary intervention (PCI) combined with stenting, a small number still suffer from recurrent restenosis which can be invalidating for the patient and frustrating for the cardiologist due to repeated PCIs. In this prospective single-centre pilot study we will test the hypothesis of three different treatment strategies to use in this special patient subset, to determine if we can find a positive 'trend' in one arm, in order to either make a selection for one of the treatment strategies, or to provide a base to expand the study into a larger multicentre randomised study. TIME COURSE AND ENROLLMENT: A total of 120 patients will be included, 40 in each treatment arm. All patients with either in-stent and/or native restenosis and/or diabetics and/or type C lesions (ACC/AHA) are eligible. The usual exclusion criteria for intracoronary brachytherapy and prolonged antiplatelet therapy are applied. All lesions <44 mm in length and with a vessel diameter 2.4>4.0 mm are suitable. Angiographic, intravascular ultrasound imaging and clinical follow-up at one year will become available in the first quarter of 2005.
RCT Entities:
DESIGN: Prospective, randomised single-centre pilot study comparing a beta with a gamma source and a sirolimus-eluting stent in patients with an estimated high risk of restenosis (40 to 50%). PURPOSE: Although the majority of patients referred for revascularisation are now being treated with percutaneous coronary intervention (PCI) combined with stenting, a small number still suffer from recurrent restenosis which can be invalidating for the patient and frustrating for the cardiologist due to repeated PCIs. In this prospective single-centre pilot study we will test the hypothesis of three different treatment strategies to use in this special patient subset, to determine if we can find a positive 'trend' in one arm, in order to either make a selection for one of the treatment strategies, or to provide a base to expand the study into a larger multicentre randomised study. TIME COURSE AND ENROLLMENT: A total of 120 patients will be included, 40 in each treatment arm. All patients with either in-stent and/or native restenosis and/or diabetics and/or type C lesions (ACC/AHA) are eligible. The usual exclusion criteria for intracoronary brachytherapy and prolonged antiplatelet therapy are applied. All lesions <44 mm in length and with a vessel diameter 2.4>4.0 mm are suitable. Angiographic, intravascular ultrasound imaging and clinical follow-up at one year will become available in the first quarter of 2005.
Authors: M Sabaté; J P Marijnissen; S G Carlier; I P Kay; W J van der Giessen; V L Coen; J M Ligthart; E Boersma; M A Costa; P C Levendag; P W Serruys Journal: Circulation Date: 2000-05-30 Impact factor: 29.690
Authors: J M Ahmed; G S Mintz; R Waksman; N J Weissman; R Mehran; A D Pichard; L F Satler; K M Kent; M B Leon Journal: Circulation Date: 2000-05-16 Impact factor: 29.690
Authors: D L Fischman; M B Leon; D S Baim; R A Schatz; M P Savage; I Penn; K Detre; L Veltri; D Ricci; M Nobuyoshi Journal: N Engl J Med Date: 1994-08-25 Impact factor: 91.245