Clinical trial NCT00856765: Drug-eluting Balloon in Acute Myocardial Infarction
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Coronary Artery Disease
Atherosclerosis
Thrombosis
Acute Myocardial Infarction
Lead sponsor: UMC Utrecht
Sponsor class: OTHER
First posted: 2009-03-06
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Angiographic in-segment late lumen loss (expressed in millimeters) as determined by quantitative coronary analysis (QCA)
timeFrame: 6 months
Secondary outcomes:
measure: Binary restenosis using QCA
timeFrame: 6 months
measure: stent malapposition and re-endothelialization assessed by Optical Coherence Tomography (OCY)
timeFrame: 6 months
measure: coronary endothelial dysfunction after acetylcholine infusion
timeFrame: 6 months
measure: Clinical outcomes (death, myocardial infarction, repeated revascularization procedures)
timeFrame: 5 years
Other outcomes:
Locations:
city: Modena
country: Italy
facility: University of Modena, Department of Cardiology
city: Utrecht
country: Netherlands
facility: UMC Utrecht
Study officials:
affiliation: UMC Utrecht
name: Pieter Stella, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.