Treatment of patients with bare metal stent restenosis remains a challenge. This study will assess which interventional strategy (paclitaxel-eluting balloon vs everolimus-eluting stent) is superior in the treatment of patients suffering from bare metal stent restenosis.
Treatment of patients with bare metal stent restenosis remains a major clinical and technical challenge. Currently, drug-eluting stents are widely used in the management of these patients. Recently, the value of the paclitaxel-eluting balloon in this clinical setting has been suggested. However, there is only scarce observational data on the value of this new balloon in patients with bare metal stent restenosis. This prospective, multicenter, randomized clinical trial will compare two different interventional strategies (namely, paclitaxel-eluting balloon vs everolimus-eluting stent) in the treatment of patients with bare metal stent restenosis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
190
Balloon angioplasty
Stent implantation
Complejo Hospitalario Universitario A Coruña
Minimal lumen diameter
Comparison of minimal lumen diameter at late angiographic follow-up (6-9 months) between the 2 treatment strategies (by quantitative coronary angiography)
Time frame: Late angiographic follow-up (6-9 months)
Combined clinical and angiographic end-points
A) Efficacy outcomes: A1) Angiographic: 1) Restenosis rate, 2) % diameter stenosis, 3) acute gain, 4) late loss, 5) net gain A2) Composite of death, myocardial infarction, target vessel revascularization and analysis of individual events B) Safety Outcomes: Stent thrombosis, Bleeding episodes. C) Pre-specified variables for subgroup analysis (RIBS I) D) Stratification (length and edge). Type of stent E) Influence of clinical variables and restenosis patterns on outcome
Time frame: 6-9 months, 1 year and 3 years
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A Coruña, A Coruña, Spain
Hospital General Universitario de Alicante
Alicante, Alicante, Spain
Complejo Hospitalario de Torrecardenas
Almería, Almeria, Spain
Hospital Universitario Infanta Cristina
Badajoz, Badajoz, Spain
Hospital Universitari Son Dureta
Palma de Mallorca, Balearic Islands, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Barcelona, Spain
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona, Spain
Hospital Clinic de Barcelona
Barcelona, Barcelona, Spain
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital Universitario Marques de Valdecilla
Santander, Cantabria, Spain
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