Drug-eluting Balloon in Acute Myocardial Infarction

UMC Utrecht150 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

150

Conditions

Coronary Artery Disease Atherosclerosis Thrombosis Acute Myocardial Infarction

Interventions

Drug eluting balloonDEVICE

Percutaneous transluminal coronary balloon angioplasty catheter eluting paclitaxel

Bare metal stentDEVICE

Bare metal stent

Drug eluting stentDEVICE

Paclitaxel eluting stent

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Angiographic in-segment late lumen loss (expressed in millimeters) as determined by quantitative coronary analysis (QCA)

Time frame: 6 months

Secondary Outcomes

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

Drug-eluting Balloon in Acute Myocardial Infarction

Overview

Conditions

Interventions

Eligibility

Locations (2)

Outcomes

Primary Outcomes

Secondary Outcomes