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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Drug eluting balloon followed immediately by implantation of bare metal stent |
|
| 2 | Active Comparator | Drug eluting stent |
|
| 3 | Active Comparator | Bare metal stent |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Drug eluting balloon | Device | Percutaneous transluminal coronary balloon angioplasty catheter eluting paclitaxel |
|
| Measure | Description | Time Frame |
|---|---|---|
| Angiographic in-segment late lumen loss (expressed in millimeters) as determined by quantitative coronary analysis (QCA) | 6 months |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pieter Stella, MD | UMC Utrecht | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Modena, Department of Cardiology | Modena | Italy | ||||
| UMC Utrecht |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22503057 | Result | Belkacemi A, Agostoni P, Nathoe HM, Voskuil M, Shao C, Van Belle E, Wildbergh T, Politi L, Doevendans PA, Sangiorgi GM, Stella PR. First results of the DEB-AMI (drug eluting balloon in acute ST-segment elevation myocardial infarction) trial: a multicenter randomized comparison of drug-eluting balloon plus bare-metal stent versus bare-metal stent versus drug-eluting stent in primary percutaneous coronary intervention with 6-month angiographic, intravascular, functional, and clinical outcomes. J Am Coll Cardiol. 2012 Jun 19;59(25):2327-37. doi: 10.1016/j.jacc.2012.02.027. Epub 2012 Apr 11. |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D050197 | Atherosclerosis |
| D013927 | Thrombosis |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D008273 | Magic |
| D054855 | Drug-Eluting Stents |
| ID | Term |
|---|---|
| D026443 | Spiritual Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D015607 | Stents |
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| Bare metal stent | Device | Bare metal stent |
|
|
| Drug eluting stent | Device | Paclitaxel eluting stent |
|
|
| 6 months |
| Clinical outcomes (death, myocardial infarction, repeated revascularization procedures) | 5 years |
| Utrecht |
| 3584 cx |
| Netherlands |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D016769 | Embolism and Thrombosis |
| D019736 |
| Prostheses and Implants |
| D004864 | Equipment and Supplies |