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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Yvonne Breuer-Otten, UMC Utrecht
ClinicalTrials.gov Identifier:
NCT00856765
First received: March 5, 2009
Last updated: April 28, 2014
Last verified: April 2014
  Purpose

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.

Condition Intervention Phase
Coronary Artery Disease
Atherosclerosis
Thrombosis
Acute Myocardial Infarction
Device: Drug eluting balloon
Device: Bare metal stent
Device: Drug eluting stent
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by UMC Utrecht:

Primary Outcome Measures:
  • Angiographic in-segment late lumen loss (expressed in millimeters) as determined by quantitative coronary analysis (QCA) [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Binary restenosis using QCA [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • stent malapposition and re-endothelialization assessed by Optical Coherence Tomography (OCY) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • coronary endothelial dysfunction after acetylcholine infusion [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Clinical outcomes (death, myocardial infarction, repeated revascularization procedures) [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Enrollment: 150
Study Start Date: March 2009
Estimated Study Completion Date: November 2015
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Drug eluting balloon followed immediately by implantation of bare metal stent
Device: Drug eluting balloon
Percutaneous transluminal coronary balloon angioplasty catheter eluting paclitaxel
Other Name: Dior (EuroCor)
Device: Bare metal stent
Bare metal stent
Other Name: Magic (EuroCor)
Active Comparator: 2
Drug eluting stent
Device: Drug eluting stent
Paclitaxel eluting stent
Other Name: Taxus Liberté (Boston scientific)
Active Comparator: 3
Bare metal stent
Device: Bare metal stent
Bare metal stent
Other Name: Magic (EuroCor)

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00856765

Locations
Italy
University of Modena, Department of Cardiology
Modena, Italy
Netherlands
UMC Utrecht
Utrecht, Netherlands, 3584 cx
Sponsors and Collaborators
UMC Utrecht
Investigators
Principal Investigator: Pieter Stella, MD UMC Utrecht
  More Information

Publications:
Responsible Party: Yvonne Breuer-Otten, Research nurse of Dr. Pieter Stella, PI of the study, UMC Utrecht
ClinicalTrials.gov Identifier: NCT00856765     History of Changes
Other Study ID Numbers: METC 08-255
Study First Received: March 5, 2009
Last Updated: April 28, 2014
Health Authority: Netherlands: Ministry of Health, Welfare and Sport
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Additional relevant MeSH terms:
Atherosclerosis
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Infarction
Myocardial Infarction
Thrombosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Heart Diseases
Ischemia
Pathologic Processes
Necrosis
Embolism and Thrombosis

ClinicalTrials.gov processed this record on July 29, 2014