The aim of the study is to compare rapamycin eluting stent and paclitaxel eluting balloon catheter in the treatment of restenosis in bare metal stent.
Study aims: * Clinical efficacy evaluation of different treatment's strategies, including periprocedural and long-term endpoints defined as: death, myocardial infarction, brain stroke, necessity of repeated revascularization * Evaluation of intravascular ultrasound (IVUS) as an optimisation method for direct and long-term revascularization effects * Evaluation of optical coherence tomography as an optimisation method for direct and long-term revascularization effects * Evaluation of late lumen loss and neointimal hyperplasia in stent in long-term follow-up * Analysis of direct and indirect medical costs of alternative treatment strategies Study group: 200 patients with symptomatic restenosis evidenced angiographically in bare metal stent implanted in native coronary artery. Patients will be randomised to 2 therapeutic groups: * Patients treated with rapamycin eluting stent (n=100) * Patients treated with paclitaxel eluting balloon catheter (n=100)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
Rapamycin eluting stent implantation for in-stent restenosis treatment
Paclitaxel eluting balloon catheter for in-stent restenosis treatment
Instytut Kardiologii w Warszawie-Aninie
Warsaw, Alpejska 42, Poland
RECRUITINGKatedra i Klinika Kardiologii Warszawskiego Uniwersytetu Medycznego
Warsaw, Banacha 1a, Poland
RECRUITINGKlinika Kardiologii z Kliniką Kardiochirurgii Uniwersyteckiego Szpitala Klinicznego w Lodzi
Lodz, Kniaziewicza 1/5, Poland
Incidence of repeated restenosis angiographically evidenced
Time frame: at 9 months
Neointimal volume assessed by intravascular ultrasound (IVUS)
Time frame: at 9 months
Late lumen loss and neointimal volume assessed by optical coherence tomography (OCT)
Time frame: at 9 months
Incidence of repeated target lesion revascularization (TLR)
Time frame: at 9 months
Incidence of repeated target vessel revascularization (TVR)
Time frame: at 9 months
Incidence of death
Time frame: at 9 months
Incidence of myocardial infarction
Time frame: at 9 months
Incidence of brain stroke
Time frame: at 9 months
Incidence of in-stent thrombosis
Time frame: at 9 months
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II Department of Cardiology Medical College Jagiellonian University University Hospital in Krakow
Krakow, Kopernika 17, Poland
RECRUITING