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

U

UMC Utrecht

Status and phase

Completed
Phase 3
Phase 2

Conditions

Coronary Artery Disease
Thrombosis
Acute Myocardial Infarction
Atherosclerosis

Treatments

Device: Drug eluting stent
Device: Bare metal stent
Device: Drug eluting balloon

Study type

Interventional

Funder types

Other

Identifiers

NCT00856765
METC 08-255

Details and patient eligibility

About

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.

Enrollment

150 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

150 participants in 3 patient groups

1
Experimental group
Description:
Drug eluting balloon followed immediately by implantation of bare metal stent
Treatment:
Device: Bare metal stent
Device: Drug eluting balloon
2
Active Comparator group
Description:
Drug eluting stent
Treatment:
Device: Drug eluting stent
3
Active Comparator group
Description:
Bare metal stent
Treatment:
Device: Bare metal stent

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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