Acute Myocardial Infarction Clinical Trial
Official title:
Study to Evaluate the Efficacy and Safety of Paclitaxel Eluting Balloon After Bare Metal Stent Implantation Versus Drug-eluting Stent in St Elevation Myocardial Infarction
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.
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