Drug-eluting Balloon in Acute Myocardial Infarction

Phase 2

Completed

• Conditions: Atherosclerosis; Thrombosis; Acute Myocardial Infarction; Coronary Artery Disease
• Interventions: Device: Drug eluting stent; Device: Bare metal stent; Device: Drug eluting balloon

• Registration Number: NCT00856765
• Lead Sponsor: UMC Utrecht

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. 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2009-03-05
• Study First Submitted QC: 2009-03-05
• Study First Posted: 2009-03-06
• Primary Completion: 2011-06
• Study Completion: 2016-11
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-01
• Last Update Posted: 2017-05-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Drug eluting stent	Drug eluting stent
3	Bare metal stent	Bare metal stent
1	Bare metal stent	Drug eluting balloon followed immediately by implantation of bare metal stent
1	Drug eluting balloon	Drug eluting balloon followed immediately by implantation of bare metal stent

Primary Outcome Measures

Name	Time	Method
Angiographic in-segment late lumen loss (expressed in millimeters) as determined by quantitative coronary analysis (QCA)	6 months

Secondary Outcome Measures

Name	Time	Method
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
Binary restenosis using QCA	6 months

Trial Locations

Locations (2)

UMC Utrecht; 🇳🇱 Utrecht, Netherlands

University of Modena, Department of Cardiology; 🇮🇹 Modena, Italy