NCT03610347

Paclitaxel Eluting Balloon After Bare Metal Stent Implantation vs. Drug-Eluting Stent in St Elevation Myocardial Infarction

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 199 (actual)
• Sponsor: Fundacion Investigacion Interhospitalaria Cardiovascular · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Acute Myocardial Infarction

Interventions

Type	Name	Description
DEVICE	Bare metal Stent plus Paclitaxel Balloon
DEVICE	Drug Eluting Stent

Timeline

• Start date: 2016-06-29
• Primary completion: 2020-01-28
• Completion: 2020-03-31
• First posted: 2018-08-01
• Last updated: 2020-05-26

Locations

16 sites across 1 country: Spain