NCT00856765

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. 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. 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. 3.To compare coronary endothelial function after primary angioplasty using drug eluting balloon/bare metal stent versus drug eluting stent versus bare metal stent.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for phase_2 coronary-artery-disease

Timeline
Completed

Started Mar 2009

Longer than P75 for phase_2 coronary-artery-disease

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

March 5, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 6, 2009

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
5.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

May 2, 2017

Status Verified

May 1, 2017

Enrollment Period

2.3 years

First QC Date

March 5, 2009

Last Update Submit

May 1, 2017

Conditions

Coronary Artery DiseaseAtherosclerosisThrombosisAcute Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

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

    6 months

Secondary Outcomes (4)

  • Binary restenosis using QCA

    6 months

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

    6 months

  • coronary endothelial dysfunction after acetylcholine infusion

    6 months

  • Clinical outcomes (death, myocardial infarction, repeated revascularization procedures)

    5 years

Study Arms (3)

1

EXPERIMENTAL

Drug eluting balloon followed immediately by implantation of bare metal stent

Device: Drug eluting balloonDevice: Bare metal stent

2

ACTIVE COMPARATOR

Drug eluting stent

Device: Drug eluting stent

3

ACTIVE COMPARATOR

Bare metal stent

Device: Bare metal stent

Interventions

Drug eluting balloonDEVICE

Percutaneous transluminal coronary balloon angioplasty catheter eluting paclitaxel

Also known as: Dior (EuroCor)
1
Bare metal stentDEVICE

Bare metal stent

Also known as: Magic (EuroCor)
13
Drug eluting stentDEVICE

Paclitaxel eluting stent

Also known as: Taxus Liberté (Boston scientific)
2

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Modena, Department of Cardiology

Modena, Italy

Location

UMC Utrecht

Utrecht, 3584 cx, Netherlands

Location

Related Publications (1)

  • 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.

    PMID: 22503057RESULT

MeSH Terms

Conditions

Coronary Artery DiseaseAtherosclerosisThrombosis

Interventions

MagicDrug-Eluting Stents

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesEmbolism and Thrombosis

Intervention Hierarchy (Ancestors)

Spiritual TherapiesComplementary TherapiesTherapeuticsStentsProstheses and ImplantsEquipment and Supplies

Study Officials

  • Pieter Stella, MD

    UMC Utrecht

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PHD.MD

Study Record Dates

First Submitted

March 5, 2009

First Posted

March 6, 2009

Study Start

March 1, 2009

Primary Completion

June 1, 2011

Study Completion

November 1, 2016

Last Updated

May 2, 2017

Record last verified: 2017-05

Locations

NL(1)IT(1)