Drug-eluting Balloon in Bifurcations Trial (DEBIUT)

U

UMC Utrecht

Status and phase

Completed
Phase 3
Phase 2

Conditions

Coronary Artery Disease
Unstable Angina
Stable Angina
Atherosclerosis

Treatments

Device: Liberté
Device: Drug eluting balloon
Device: Taxus
Device: PTCA balloon catheter

Study type

Interventional

Funder types

Other

Identifiers

NCT00857441
CRF8025

Details and patient eligibility

About

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.

Enrollment

120 patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

120 participants in 3 patient groups

1
Experimental group
Description:
Use of Dior balloon and implant of Liberté Bare Metal Stent
Treatment:
Device: Drug eluting balloon
Device: Liberté
2
Active Comparator group
Description:
Use of standard balloon and implant of Liberté Bare Metal Stent
Treatment:
Device: PTCA balloon catheter
Device: Liberté
3
Active Comparator group
Description:
Use of standard balloon and implant of Taxus Liberté Drug Eluting Stent
Treatment:
Device: PTCA balloon catheter
Device: Taxus

Trial contacts and locations

3

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems