Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
150 participants
INTERVENTIONAL
2009-03-31
2016-11-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
Drug eluting balloon followed immediately by implantation of bare metal stent
Drug eluting balloon
Percutaneous transluminal coronary balloon angioplasty catheter eluting paclitaxel
Bare metal stent
Bare metal stent
2
Drug eluting stent
Drug eluting stent
Paclitaxel eluting stent
3
Bare metal stent
Bare metal stent
Bare metal stent
Interventions
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Drug eluting balloon
Percutaneous transluminal coronary balloon angioplasty catheter eluting paclitaxel
Bare metal stent
Bare metal stent
Drug eluting stent
Paclitaxel eluting stent
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
80 Years
ALL
No
Sponsors
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UMC Utrecht
OTHER
Responsible Party
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Prof. Pieter Stella
PHD.MD
Principal Investigators
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Pieter Stella, MD
Role: PRINCIPAL_INVESTIGATOR
UMC Utrecht
Locations
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University of Modena, Department of Cardiology
Modena, , Italy
UMC Utrecht
Utrecht, , Netherlands
Countries
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References
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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.
Other Identifiers
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METC 08-255
Identifier Type: -
Identifier Source: org_study_id
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