Drug-eluting Balloon in Bifurcations Trial (DEBIUT)

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)

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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