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Drug-eluting Balloon in Bifurcations Trial (DEBIUT)

Primary Purpose

Coronary Artery Disease, Atherosclerosis, Stable Angina

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Drug eluting balloon
Liberté
PTCA balloon catheter
Taxus
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 - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Stable angina pectoris (CCS class 1,2,3,4) or unstable angina and documented ischemia or silent ischemia
  • Patients eligible for coronary revascularisation
  • The target bifurcation lesion has a major native coronary artery (>2.5mm) with a stenosis > 50% (on visual assessment) located at a side branch (>2mm)
  • Patient must be acceptable for CABG
  • De novo lesion
  • The main vessel lesion can be covered by one stent (up to 32mm)
  • Only one target lesion can be included in the study: other lesions in different vessels are successfully treated before the treatment of the target lesion (residual stenosis <30%, stent well deployed, no residual dissection, normal TIMI flow, no chest pain, ECG unchanged compared to pre-procedural ECG)
  • Signed patients informed consent

Exclusion Criteria:

  • Patient unable to give informed consent
  • Patients with a previous PCI in the target vessel
  • Patients with in stent restenosis of target lesion
  • Left ventricular ejection fraction more than 30%
  • Patients with left main disease
  • Severe calcifications with an undilatable lesion during balloon predilatation
  • History of bleeding diathesis
  • Untreated significant lesion greater than 50% diameter stenosis remaining proximal or distal to the target intervention.
  • Patient has suffered a stroke or TIA within the past 3 months
  • Life expectancy < 1 year
  • Any major surgery planned or required during the next 6 months
  • Acute Myocardial Infarction
  • Only one target lesion can be included in the study
  • Allergy to contrast and/or required anti-platelet medication
  • Patients unwilling to return for follow-up at 6 months

Sites / Locations

  • Oost-Limburg Ziekenhuis
  • Gasthuisberg Leuven
  • 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

Use of Dior balloon and implant of Liberté Bare Metal Stent

Use of standard balloon and implant of Liberté Bare Metal Stent

Use of standard balloon and implant of Taxus Liberté Drug Eluting Stent

Outcomes

Primary Outcome Measures

Side branch angiographic Late Lumen Loss (expressed in millimeters) measured by Quantitative Coronary Analysis (QCA)

Secondary Outcome Measures

Target vessel failure (TVF)
Major Angiographic coronary or cerebral Events (MACCE)

Full Information

First Posted
March 5, 2009
Last Updated
July 16, 2015
Sponsor
UMC Utrecht
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1. Study Identification

Unique Protocol Identification Number
NCT00857441
Brief Title
Drug-eluting Balloon in Bifurcations Trial
Acronym
DEBIUT
Official Title
A Prospective Three-arm Multi-center Study to Investigate Procedural, Clinical and Angiographic Outcomes Using a Drug Eluting Balloon Versus a Standard Balloon in Combination With a Bare Metal Stent and a DES Stent, Following the Provisional Side Branch T-stenting Approach, in Patients With Complex Lesions
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
January 2015 (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 purpose of the DEBIUT study is to assess procedural, clinical and angiographic outcomes of: Provisional T-stenting use for dilation the Paclitaxel-eluting PCI-balloon (DiorTM) in comparison to dilation with a standard balloon prior to the implant of the Liberty Bare Metal Stent in bifurcation lesions (with side branch involvement). Comparison of the results above with the results of using a standard balloon prior to provisional T-stenting with the Paclitaxel-eluting stent TaxusTM LibertéTM.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Atherosclerosis, Stable Angina, Unstable Angina

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Use of Dior balloon and implant of Liberté Bare Metal Stent
Arm Title
2
Arm Type
Active Comparator
Arm Description
Use of standard balloon and implant of Liberté Bare Metal Stent
Arm Title
3
Arm Type
Active Comparator
Arm Description
Use of standard balloon and implant of Taxus Liberté Drug Eluting 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)
Liberté
Other Intervention Name(s)
Liberté (Boston Scientific)
Intervention Description
Bare metal stent
Intervention Type
Device
Intervention Name(s)
PTCA balloon catheter
Other Intervention Name(s)
Any PTCA catheter
Intervention Description
Percutaneous transluminal coronary angioplasty catheter
Intervention Type
Device
Intervention Name(s)
Taxus
Other Intervention Name(s)
Taxus Liberté (Boston scientific)
Intervention Description
Paclitaxel eluting stent
Primary Outcome Measure Information:
Title
Side branch angiographic Late Lumen Loss (expressed in millimeters) measured by Quantitative Coronary Analysis (QCA)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Target vessel failure (TVF)
Time Frame
6 months
Title
Major Angiographic coronary or cerebral Events (MACCE)
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Stable angina pectoris (CCS class 1,2,3,4) or unstable angina and documented ischemia or silent ischemia Patients eligible for coronary revascularisation The target bifurcation lesion has a major native coronary artery (>2.5mm) with a stenosis > 50% (on visual assessment) located at a side branch (>2mm) Patient must be acceptable for CABG De novo lesion The main vessel lesion can be covered by one stent (up to 32mm) Only one target lesion can be included in the study: other lesions in different vessels are successfully treated before the treatment of the target lesion (residual stenosis <30%, stent well deployed, no residual dissection, normal TIMI flow, no chest pain, ECG unchanged compared to pre-procedural ECG) Signed patients informed consent Exclusion Criteria: Patient unable to give informed consent Patients with a previous PCI in the target vessel Patients with in stent restenosis of target lesion Left ventricular ejection fraction more than 30% Patients with left main disease Severe calcifications with an undilatable lesion during balloon predilatation History of bleeding diathesis Untreated significant lesion greater than 50% diameter stenosis remaining proximal or distal to the target intervention. Patient has suffered a stroke or TIA within the past 3 months Life expectancy < 1 year Any major surgery planned or required during the next 6 months Acute Myocardial Infarction Only one target lesion can be included in the study Allergy to contrast and/or required anti-platelet medication Patients unwilling to return for follow-up at 6 months
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
Oost-Limburg Ziekenhuis
City
Genk
Country
Belgium
Facility Name
Gasthuisberg Leuven
City
Leuven
Country
Belgium
Facility Name
UMC Utrecht
City
Utrecht
ZIP/Postal Code
3584 cx
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
22027731
Citation
Belkacemi A, Agostoni P, Voskuil M, Stella PR. Coronary bifurcation lesions treated with the drug-eluting balloon: a preliminary insight from the DEBIUT study. EuroIntervention. 2011 May;7 Suppl K:K66-9. doi: 10.4244/EIJV7SKA12.
Results Reference
derived

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Drug-eluting Balloon in Bifurcations Trial

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