NCT00856765

Drug-eluting Balloon in Acute Myocardial Infarction

Randomized Comparison of Drug Eluting Balloon/Bare Metal Stent Versus Drug Eluting Stent Versus Bare Metal Stent for the Treatment of Patients With Acute ST-elevation Myocardial Infarction

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: UMC Utrecht · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The investigators hypothesize that patients with Acute ST Elevation Myocardial Infarction may benefit from primary angioplasty with use of a drug eluting balloon/bare metal stent combination without impairing the process of normal vascular healing and endothelial function. The goals of this study are: 1. To compare 6-month angiographic outcome after primary angioplasty using drug eluting balloon/bare metal stent combination versus drug eluting stent versus bare metal stent. 2. To compare stent apposition and stent endothelialization after primary angioplasty using drug eluting balloon/bare metal stent versus drug eluting stent versus bare metal stent. 3. To compare coronary endothelial function after primary angioplasty using drug eluting balloon/bare metal stent versus drug eluting stent versus bare metal stent.

Conditions

• Coronary Artery Disease
• Atherosclerosis
• Thrombosis
• Acute Myocardial Infarction

Interventions

Type	Name	Description
DEVICE	Drug eluting balloon	Percutaneous transluminal coronary balloon angioplasty catheter eluting paclitaxel
DEVICE	Bare metal stent	Bare metal stent
DEVICE	Drug eluting stent	Paclitaxel eluting stent

Timeline

• Start date: 2009-03-01
• Primary completion: 2011-06-01
• Completion: 2016-11-01
• First posted: 2009-03-06
• Last updated: 2017-05-02

Locations

2 sites across 2 countries: Italy, Netherlands