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

May 1, 2017 updated by: Prof. Pieter Stella, UMC Utrecht

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Modena, Italy
        • University of Modena, Department of Cardiology
  • Netherlands
      • Utrecht, Netherlands, 3584 CX
        • UMC Utrecht

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Dior (EuroCor)
Device: Bare metal stent
Bare metal stent
Other Names:
  • Magic (EuroCor)
Active Comparator: 2
Drug eluting stent
Device: Drug eluting stent
Paclitaxel eluting stent
Other Names:
  • Taxus Liberté (Boston scientific)
Active Comparator: 3
Bare metal stent
Device: Bare metal stent
Bare metal stent
Other Names:
  • Magic (EuroCor)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UMC Utrecht

Investigators

  • Principal Investigator: Pieter Stella, MD, UMC Utrecht

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

November 1, 2016

Study Registration Dates

First Submitted

March 5, 2009

First Submitted That Met QC Criteria

March 5, 2009

First Posted (Estimate)

March 6, 2009

Study Record Updates

Last Update Posted (Actual)

May 2, 2017

Last Update Submitted That Met QC Criteria

May 1, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • METC 08-255

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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