Coronary Artery Disease, Atherosclerosis, Thrombosis, Acute Myocardial Infarction
Conditions
Brief 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.
Interventions
DEVICEDrug eluting balloon
Percutaneous transluminal coronary balloon angioplasty catheter eluting paclitaxel
DEVICEBare metal stent
Bare metal stent
DEVICEDrug eluting stent
Paclitaxel eluting stent
Sponsors
UMC Utrecht
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Angiographic in-segment late lumen loss (expressed in millimeters) as determined by quantitative coronary analysis (QCA) | 6 months |
Secondary
| Measure | 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 |
Countries
Italy, Netherlands
Outcome results
None listed