Drug-eluting Balloon in Bifurcations Trial (DEBIUT)

July 16, 2015 updated by: Prof. Pieter Stella, UMC Utrecht

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

The purpose of the DEBIUT study is to assess procedural, clinical and angiographic outcomes of:

  1. 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).
  2. 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Genk, Belgium
        • Oost-Limburg Ziekenhuis
      • Leuven, Belgium
        • Gasthuisberg Leuven
  • Netherlands
      • Utrecht, Netherlands, 3584 CX
        • UMC Utrecht

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Use of Dior balloon and implant of Liberté Bare Metal Stent
Device: Drug eluting balloon
Percutaneous transluminal coronary balloon angioplasty catheter eluting paclitaxel
Other Names:
  • Dior (EuroCor)
Device: Liberté
Bare metal stent
Other Names:
  • Liberté (Boston Scientific)
Active Comparator: 2
Use of standard balloon and implant of Liberté Bare Metal Stent
Device: Liberté
Bare metal stent
Other Names:
  • Liberté (Boston Scientific)
Device: PTCA balloon catheter
Percutaneous transluminal coronary angioplasty catheter
Other Names:
  • Any PTCA catheter
Active Comparator: 3
Use of standard balloon and implant of Taxus Liberté Drug Eluting Stent
Device: PTCA balloon catheter
Percutaneous transluminal coronary angioplasty catheter
Other Names:
  • Any PTCA catheter
Device: Taxus
Paclitaxel eluting stent
Other Names:
  • Taxus Liberté (Boston scientific)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Side branch angiographic Late Lumen Loss (expressed in millimeters) measured by Quantitative Coronary Analysis (QCA)
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Target vessel failure (TVF)
Time Frame: 6 months
6 months
Major Angiographic coronary or cerebral Events (MACCE)
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UMC Utrecht

Investigators

  • Principal Investigator: Pieter Stella, MD, UMC Utrecht

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

September 1, 2009

Study Completion (Actual)

January 1, 2015

Study Registration Dates

First Submitted

March 5, 2009

First Submitted That Met QC Criteria

March 5, 2009

First Posted (Estimate)

March 6, 2009

Study Record Updates

Last Update Posted (Estimate)

July 20, 2015

Last Update Submitted That Met QC Criteria

July 16, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRF8025

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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