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Drug-eluting Balloon in Acute Myocardial Infarction (DEB-AMI)

This study is currently recruiting participants.
Verified March 2009 by UMC Utrecht
Sponsor:
Information provided by:
UMC Utrecht
ClinicalTrials.gov Identifier:
NCT00856765
First received: March 5, 2009
Last updated: June 29, 2010
Last verified: March 2009
History of Changes

March 5, 2009
June 29, 2010
March 2009
March 2013   (final data collection date for primary outcome measure)
Angiographic in-segment late lumen loss (expressed in millimeters) as determined by quantitative coronary analysis (QCA) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00856765 on ClinicalTrials.gov Archive Site
  • Binary restenosis using QCA [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • stent malapposition and re-endothelialization assessed by Optical Coherence Tomography (OCY) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • coronary endothelial dysfunction after acetylcholine infusion [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Clinical outcomes (death, myocardial infarction, repeated revascularization procedures) [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Drug-eluting Balloon in Acute Myocardial Infarction
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

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.
Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Coronary Artery Disease
  • Atherosclerosis
  • Thrombosis
  • Acute Myocardial Infarction
  • Device: Drug eluting balloon
    Percutaneous transluminal coronary balloon angioplasty catheter eluting paclitaxel
    Other Name: Dior (EuroCor)
  • Device: Bare metal stent
    Bare metal stent
    Other Name: Magic (EuroCor)
  • Device: Drug eluting stent
    Paclitaxel eluting stent
    Other Name: Taxus Liberté (Boston scientific)
  • Experimental: 1
    Drug eluting balloon followed immediately by implantation of bare metal stent
    Interventions:
    • Device: Drug eluting balloon
    • Device: Bare metal stent
  • Active Comparator: 2
    Drug eluting stent
    Intervention: Device: Drug eluting stent
  • Active Comparator: 3
    Bare metal stent
    Intervention: Device: Bare metal stent
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. Epub 2012 Apr 11.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
150
March 2018
March 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact: Pieter Stella, MD +31887556167 p.stella@umcutrecht.nl
Italy,   Netherlands
 
NCT00856765
METC 08-255
Yes
Dr. Pieter Stella, UMC Utrecht
UMC Utrecht
Not Provided
Principal Investigator: Pieter Stella, MD UMC Utrecht
UMC Utrecht
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP