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

Primary Purpose

Coronary Artery Disease, Atherosclerosis, Thrombosis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Drug eluting balloon
Bare metal stent
Drug eluting stent
Sponsored by
UMC Utrecht
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University of Modena, Department of Cardiology
  • UMC Utrecht

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

1

2

3

Arm Description

Drug eluting balloon followed immediately by implantation of bare metal stent

Drug eluting stent

Bare metal stent

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Binary restenosis using QCA
stent malapposition and re-endothelialization assessed by Optical Coherence Tomography (OCY)
coronary endothelial dysfunction after acetylcholine infusion
Clinical outcomes (death, myocardial infarction, repeated revascularization procedures)

Full Information

First Posted
March 5, 2009
Last Updated
May 1, 2017
Sponsor
UMC Utrecht
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1. Study Identification

Unique Protocol Identification Number
NCT00856765
Brief Title
Drug-eluting Balloon in Acute Myocardial Infarction
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
November 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
UMC Utrecht

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Atherosclerosis, Thrombosis, Acute Myocardial Infarction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Drug eluting balloon followed immediately by implantation of bare metal stent
Arm Title
2
Arm Type
Active Comparator
Arm Description
Drug eluting stent
Arm Title
3
Arm Type
Active Comparator
Arm Description
Bare metal stent
Intervention Type
Device
Intervention Name(s)
Drug eluting balloon
Other Intervention Name(s)
Dior (EuroCor)
Intervention Description
Percutaneous transluminal coronary balloon angioplasty catheter eluting paclitaxel
Intervention Type
Device
Intervention Name(s)
Bare metal stent
Other Intervention Name(s)
Magic (EuroCor)
Intervention Description
Bare metal stent
Intervention Type
Device
Intervention Name(s)
Drug eluting stent
Other Intervention Name(s)
Taxus Liberté (Boston scientific)
Intervention Description
Paclitaxel eluting stent
Primary Outcome Measure Information:
Title
Angiographic in-segment late lumen loss (expressed in millimeters) as determined by quantitative coronary analysis (QCA)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Binary restenosis using QCA
Time Frame
6 months
Title
stent malapposition and re-endothelialization assessed by Optical Coherence Tomography (OCY)
Time Frame
6 months
Title
coronary endothelial dysfunction after acetylcholine infusion
Time Frame
6 months
Title
Clinical outcomes (death, myocardial infarction, repeated revascularization procedures)
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pieter Stella, MD
Organizational Affiliation
UMC Utrecht
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Modena, Department of Cardiology
City
Modena
Country
Italy
Facility Name
UMC Utrecht
City
Utrecht
ZIP/Postal Code
3584 cx
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
22503057
Citation
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.
Results Reference
result

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Drug-eluting Balloon in Acute Myocardial Infarction

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