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OpenTrials
Completed

NCT Number: NCT00856765

Drug-eluting Balloon in Acute 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.

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Key information

Conditions

Coronary Artery Disease Acute Myocardial Infarction Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Coronary Disease Embolism and Thrombosis Heart Diseases Myocardial Ischemia Thrombosis Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

University of Modena, Department of Cardiology, Modena, Italy

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Drug Eluting Balloon

Device

Percutaneous transluminal coronary balloon angioplasty catheter eluting paclitaxel

Other names: Dior (EuroCor)

Bare Metal Stent

Device

Bare metal stent

Other names: Magic (EuroCor)

Drug eluting stent

Device

Paclitaxel eluting stent

Other names: Taxus Liberté (Boston scientific)

Primary outcomes

  1. Angiographic in-segment late lumen loss (expressed in millimeters) as determined by quantitative coronary analysis (QCA)

    Time frame: 6 months

Secondary outcomes

  1. Binary restenosis using QCA

    Time frame: 6 months

  2. stent malapposition and re-endothelialization assessed by Optical Coherence Tomography (OCY)

    Time frame: 6 months

  3. coronary endothelial dysfunction after acetylcholine infusion

    Time frame: 6 months

  4. Clinical outcomes (death, myocardial infarction, repeated revascularization procedures)

    Time frame: 5 years

Sponsors and collaborators

Lead sponsor

UMC Utrecht

Other

Registry information

Official study 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

Acronym: DEB-AMI

Important dates

Study start
2009
Primary completion
2011
Study completion
2016
First posted
Mar 6, 2009
Registry last updated
May 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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