Drug-eluting Balloon in Acute Myocardial Infarction

Study Overview
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Brief Summary
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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: 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. 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. To compare coronary endothelial function after primary angioplasty using drug eluting balloon/bare metal stent versus drug eluting stent versus bare metal stent.

Official Title
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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

Conditions
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Coronary Artery Disease, Atherosclerosis, Thrombosis, Acute Myocardial Infarction

Intervention / Treatment
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* Device: Drug eluting balloon
* Device: Bare metal stent
* Device: Drug eluting stent


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Drug eluting balloon followed immediately by implantation of bare metal stent | Device: Drug eluting balloon<br>* Percutaneous transluminal coronary balloon angioplasty catheter eluting paclitaxel<br>* Other names: Dior (EuroCor);Device: Bare metal stent<br>* Bare metal stent<br>* Other names: Magic (EuroCor);|
| Active Comparator: 2<br>Drug eluting stent | Device: Drug eluting stent<br>* Paclitaxel eluting stent<br>* Other names: Taxus Liberté (Boston scientific);|
| Active Comparator: 3<br>Bare metal stent | Device: Bare metal stent<br>* Bare metal stent<br>* Other names: Magic (EuroCor);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Angiographic in-segment late lumen loss (expressed in millimeters) as determined by quantitative coronary analysis (QCA) |  | 6 months | 

Secondary Outcome Measures

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