Overview

This trial is active, not recruiting.

Conditions coronary artery disease, atherosclerosis, thrombosis, acute myocardial infarction
Treatments drug eluting balloon, bare metal stent, drug eluting stent
Phase phase 2/phase 3
Sponsor UMC Utrecht
Start date March 2009
End date June 2011
Trial size 150 participants
Trial identifier NCT00856765, METC 08-255

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Drug eluting balloon followed immediately by implantation of bare metal stent
drug eluting balloon Dior (EuroCor)
Percutaneous transluminal coronary balloon angioplasty catheter eluting paclitaxel
bare metal stent Magic (EuroCor)
Bare metal stent
(Active Comparator)
Drug eluting stent
drug eluting stent Taxus Liberté (Boston scientific)
Paclitaxel eluting stent
(Active Comparator)
Bare metal stent
bare metal stent Magic (EuroCor)
Bare metal stent

Primary Outcomes

Measure
Angiographic in-segment late lumen loss (expressed in millimeters) as determined by quantitative coronary analysis (QCA)
time frame: 6 months

Secondary Outcomes

Measure
Binary restenosis using QCA
time frame: 6 months
stent malapposition and re-endothelialization assessed by Optical Coherence Tomography (OCY)
time frame: 6 months
coronary endothelial dysfunction after acetylcholine infusion
time frame: 6 months
Clinical outcomes (death, myocardial infarction, repeated revascularization procedures)
time frame: 5 years

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

Inclusion Criteria: - STEMI within 12 hours of onset of complaints - Candidate for primary PCI with stent-implantation - Successful thrombus aspiration defined by no angiographic signs of thrombus a the site of plaque rupture and TIMI flow more or equal 1 Exclusion Criteria: - Unable to give written informed consent - Diabetes and Type C- coronary lesion - Previous PCI or CABG of infarct related vessel - Left main stenosis more than 50%. - Triple vessel disease with stenosis more than 50% in 3 epicardial coronary arteries - Target vessel reference diameter less than 2.5 and more than 4.0 mm - Target lesion length more than 25 mm - Intolerance for aspirin or clopidogrel - Life expectancy less than 12 months - Women with child bearing potential

Additional Information

Official title 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
Principal investigator Pieter Stella, MD
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by UMC Utrecht.