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

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)

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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