Drug-eluting Balloon in Bifurcations Trial

Phase 2

Completed

• Conditions: Atherosclerosis; Unstable Angina; Coronary Artery Disease; Stable Angina
• Interventions: Device: Drug eluting balloon; Device: Liberté; Device: PTCA balloon catheter; Device: Taxus

• Registration Number: NCT00857441
• Lead Sponsor: UMC Utrecht

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2009-03-05
• Study First Submitted QC: 2009-03-05
• Study First Posted: 2009-03-06
• Primary Completion: 2009-09
• Study Completion: 2015-01
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-16
• Last Update Posted: 2015-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Liberté	Use of Dior balloon and implant of Liberté Bare Metal Stent
2	Liberté	Use of standard balloon and implant of Liberté Bare Metal Stent
1	Drug eluting balloon	Use of Dior balloon and implant of Liberté Bare Metal Stent
2	PTCA balloon catheter	Use of standard balloon and implant of Liberté Bare Metal Stent
3	PTCA balloon catheter	Use of standard balloon and implant of Taxus Liberté Drug Eluting Stent
3	Taxus	Use of standard balloon and implant of Taxus Liberté Drug Eluting Stent

Primary Outcome Measures

Name	Time	Method
Side branch angiographic Late Lumen Loss (expressed in millimeters) measured by Quantitative Coronary Analysis (QCA)	6 months

Secondary Outcome Measures

Name	Time	Method
Major Angiographic coronary or cerebral Events (MACCE)	6 months
Target vessel failure (TVF)	6 months

Trial Locations

Locations (3)

UMC Utrecht; 🇳🇱 Utrecht, Netherlands

Gasthuisberg Leuven; 🇧🇪 Leuven, Belgium

Oost-Limburg Ziekenhuis; 🇧🇪 Genk, Belgium