NCT00857441

Drug-eluting Balloon in Bifurcations Trial

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: UMC Utrecht · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Coronary Artery Disease
• Atherosclerosis
• Stable Angina
• Unstable Angina

Interventions

Type	Name	Description
DEVICE	Drug eluting balloon	Percutaneous transluminal coronary balloon angioplasty catheter eluting paclitaxel
DEVICE	Liberté	Bare metal stent
DEVICE	PTCA balloon catheter	Percutaneous transluminal coronary angioplasty catheter
DEVICE	Taxus	Paclitaxel eluting stent

Timeline

• Start date: 2008-01-01
• Primary completion: 2009-09-01
• Completion: 2015-01-01
• First posted: 2009-03-06
• Last updated: 2015-07-20

Locations

3 sites across 2 countries: Belgium, Netherlands