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Completed

NCT Number: NCT00857441

Drug-eluting Balloon in Bifurcations Trial

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.

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Key information

Conditions

Coronary Artery Disease Angina Pectoris Angina, Stable Angina, Unstable Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Chest Pain Coronary Disease Heart Diseases Myocardial Ischemia Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Stable Angina Unstable Angina Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Oost-Limburg Ziekenhuis, Genk, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Drug Eluting Balloon

Device

Percutaneous transluminal coronary balloon angioplasty catheter eluting paclitaxel

Other names: Dior (EuroCor)

Liberté

Device

Bare metal stent

Other names: Liberté (Boston Scientific)

PTCA balloon catheter

Device

Percutaneous transluminal coronary angioplasty catheter

Other names: Any PTCA catheter

Taxus

Device

Paclitaxel eluting stent

Other names: Taxus Liberté (Boston scientific)

Primary outcomes

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

    Time frame: 6 months

Secondary outcomes

  1. Target vessel failure (TVF)

    Time frame: 6 months

  2. Major Angiographic coronary or cerebral Events (MACCE)

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

UMC Utrecht

Other

Registry information

Official study 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

Acronym: DEBIUT

Important dates

Study start
2008
Primary completion
2009
Study completion
2015
First posted
Mar 6, 2009
Registry last updated
Jul 20, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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