Study objective is the evaluation of safety and efficacy at 12 months of the combination treatment of bare metal Stent plus Paclitaxel Eluting Balloon vs drug eluting stent in patients with ST-elevation myocardial infarction with less than 12 hours of evolution.
This is a multicenter, prospective, randomized, open study After the permeabilization of the clinical event responsible artery patients will be randomized in a 1:1 ratio to one of the following treatment groups: Group 1: insertion of a bare metal stent with post-dilatation with a paclitaxel eluting balloon (Pantera Lux ®) Group 2: insertion of a drug elution stent Patients (or their legal representative) must sign the consent before randomization. Patients will be monitored 30 days after surgery, at 6 and 12 months. The primary efficacy endpoint is Target Vessel Failure (TVF) at 12 months This study will involve patients over 18 years old with STEMI, or new left bundle branch block or posterior AMI (ECG) that occur within 12 hours of onset of symptoms. A total of 516 patients will be included.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
199
H. U. Son Espases
Palma de Mallorca, Balearic Islands, Spain
H. U. Puerto Real
Puerto Real, Cádiz, Spain
H. U. de Bellvitge
L'Hospitalet de Llobregat, H. U. de Bellvitge, Spain
Target Vessel Failure (TVF)
Efficacy: TVF define as a the composite of cardiac death, target-vessel myocardial infarction, or ischemia-driven target-lesion revascularization
Time frame: 1 year
Target Lesion Revascularization (TLR)
Efficacy: ischemia-driven target-lesion revascularization
Time frame: 1 year
Major Adverse Cardiac Events (MACE)
Safety: Major Adverse Cardiac Events (MACE) at 12 months (death, re-infarction, acute cardiovascular disease, hemorrhagy and/or stent thrombosis).
Time frame: 1 year
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Complejo Hospitalario U. de Albacete
Albacete, Spain
H. del Mar
Barcelona, Spain
H. U. Vall D'Hebron
Barcelona, Spain
H. Clínic
Barcelona, Spain
H. General U. de Ciudad Real
Ciudad Real, Spain
H. U. Virgen de las Nieves
Granada, Spain
H. U. de La Princesa
Madrid, Spain
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