Study objective is the evaluation of safety and efficacy at 9 months of combination treatment of bare metal Stent plus Paclitaxel Eluting Balloon vs bare metal stent (conventional treatment) in patients with acute myocardial infarction with systolic time elevation of less than 12 hours of evolution.
This is a multicenter, prospective, randomized, open study After the permeabilization of the clinical event responsible artery and the insertion of a bare metal stent, patients will be randomized in a 1:1 ratio to one of the following treatment groups: Group 1: post-dilatation with a paclitaxel eluting balloon (Pantera Lux ®) Group 2: no post-dilatation Patients (or their legal representative) must sign the consent before randomization. After surgery, patients will be treated with dual antiplatelet therapy (aspirin plus clopidogrel) for at least one month to group 2 patients; and at least 3 months in those who are also treated with the paclitaxel eluting balloon (group 1). Aspirin is prescribed indefinitely according to the usual practice in these patients. Patients will be monitored 30 days after surgery, at 6 and 12 months, and the ninth month (in which patient will receive an angiographic control). The primary efficacy endpoint is late lumen loss (PLT) comparing it value during surgery and control angiography at 9 months This study will involve patients over 18 years olds with systolic time elevation myocardial infarction, or new left bundle branch block or posterior AMI (ECG) that occur within 12 hours of onset of symptoms to treatment by primary angioplasty. They include a total of 220 patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
NONE
Enrollment
202
After the permeabilization of the clinical event responsible artery with conventional therapy (including the insertion of a conventional metal stent and once by the interventional cardiologist gives good final result), patients will be randomized in a 1:1 ratio
After the permeabilization of the clinical event responsible artery with conventional therapy a conventional metal stent will be inserted. Once by the interventional cardiologist gives good final result), patients will be randomized in a 1:1 ratio
Complexo Hospitalario de Santiago
Santiago de Compostela, A Coruña, Spain
Hospital General Universitario de Albacete
Albacete, Albacete, Spain
Late Luminal Loss
Loss measured in millimeters of late luminal space in vessels
Time frame: 1 year
Efficacy
Efficacy: angiography restenosis, minimal luminal diameter, ischemia directed target vessel revascularization (TVR), MACE (death, infarction, TVR)
Time frame: 1 year
Safety
Safety: MACE/ month, at 6 months and 12 months (death, re-infarction, acute cardiovascular disease, hemorrhagy and/or stent thrombosis).
Time frame: 1 year
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H. Regional Universitario Infanta Cristina
Badajoz, Badajoz, Spain
Hospital Son Espases
Palma de Mallorca, Balearic Islands, Spain
Hospital del Mar
Barcelona, Barcelona, Spain
Hospital Universitario Valle de Hebrón
Barcelona, Barcelona, Spain
Hospital Clinic i Provincial
Barcelona, Barcelona, Spain
Hospital San Pedro de Alcantara
Cáceres, Cáceres, Spain
Hospital Universitario Puerto Real
Puerto Real, Cádiz, Spain
Hospital Universitario Virgen de las Nieves
Granada, Granada, Spain
...and 9 more locations