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

This study has been completed.
Information provided by (Responsible Party):
Prof. Pieter Stella, UMC Utrecht Identifier:
First received: March 5, 2009
Last updated: May 1, 2017
Last verified: May 2017

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.

Condition Intervention Phase
Coronary Artery Disease
Acute Myocardial Infarction
Device: Drug eluting balloon
Device: Bare metal stent
Device: Drug eluting stent
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Prof. Pieter Stella, UMC Utrecht:

Primary Outcome Measures:
  • Angiographic in-segment late lumen loss (expressed in millimeters) as determined by quantitative coronary analysis (QCA) [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • Binary restenosis using QCA [ Time Frame: 6 months ]
  • stent malapposition and re-endothelialization assessed by Optical Coherence Tomography (OCY) [ Time Frame: 6 months ]
  • coronary endothelial dysfunction after acetylcholine infusion [ Time Frame: 6 months ]
  • Clinical outcomes (death, myocardial infarction, repeated revascularization procedures) [ Time Frame: 5 years ]

Enrollment: 150
Study Start Date: March 2009
Study Completion Date: November 2016
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Drug eluting balloon followed immediately by implantation of bare metal stent
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)
Active Comparator: 2
Drug eluting stent
Device: Drug eluting stent
Paclitaxel eluting stent
Other Name: Taxus Liberté (Boston scientific)
Active Comparator: 3
Bare metal stent
Device: Bare metal stent
Bare metal stent
Other Name: Magic (EuroCor)


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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
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Please refer to this study by its identifier: NCT00856765

University of Modena, Department of Cardiology
Modena, Italy
UMC Utrecht
Utrecht, Netherlands, 3584 cx
Sponsors and Collaborators
UMC Utrecht
Principal Investigator: Pieter Stella, MD UMC Utrecht
  More Information

Responsible Party: Prof. Pieter Stella, PHD.MD, UMC Utrecht Identifier: NCT00856765     History of Changes
Other Study ID Numbers: METC 08-255
Study First Received: March 5, 2009
Last Updated: May 1, 2017

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Myocardial Infarction
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Embolism and Thrombosis processed this record on May 25, 2017