Drug-eluting Balloon in Acute Myocardial Infarction

Coronary Artery Disease Clinical Trial

— DEB-AMI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00856765
• Other study ID #: METC 08-255
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: March 5, 2009
• Last updated: May 1, 2017
• Start date: March 2009
• Est. completion date: November 2016

Study information

• Verified date: May 2017
• Source: UMC Utrecht
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: November 2016
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Atherosclerosis
• Coronary Artery Disease
• Coronary Disease
• Infarction
• Myocardial Infarction
• Myocardial Ischemia
• Thrombosis

Intervention

Device:
• Drug eluting balloon
Percutaneous transluminal coronary balloon angioplasty catheter eluting paclitaxel
• Bare metal stent
Bare metal stent
• Drug eluting stent
Paclitaxel eluting stent

Locations

Country	Name	City	State
Italy	University of Modena, Department of Cardiology	Modena
Netherlands	UMC Utrecht	Utrecht

Sponsors (1)

Lead Sponsor	Collaborator
UMC Utrecht

Countries where clinical trial is conducted

Italy,  Netherlands, 

References & 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Angiographic in-segment late lumen loss (expressed in millimeters) as determined by quantitative coronary analysis (QCA)		6 months
Secondary	Binary restenosis using QCA		6 months
Secondary	stent malapposition and re-endothelialization assessed by Optical Coherence Tomography (OCY)		6 months
Secondary	coronary endothelial dysfunction after acetylcholine infusion		6 months
Secondary	Clinical outcomes (death, myocardial infarction, repeated revascularization procedures)		5 years