Paclitaxel Eluting Balloon in St Elevation Myocardial Infarction — PEBSI-01  

Acute Myocardial Infarction Clinical Trial

Official title: Study to Evaluate the Efficacy and Safety of Paclitaxel Eluting Balloon in St Elevation Myocardial Infarction After Bare Metal Stent Insertion

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Infarction
• Myocardial Infarction

• NCT number: NCT01839890
• Study type: Interventional
• Source: Fundación Médica para la Investigación y Desarrollo en el Area Cardiovascular
• Status: Completed
• Phase: Phase 3
• Start date: April 2012
• Completion date: June 2014