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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
Percutaneous transluminal coronary balloon angioplasty catheter eluting paclitaxel
Bare metal stent
Percutaneous transluminal coronary angioplasty catheter
Oost-Limburg Ziekenhuis
Genk, Belgium
Gasthuisberg Leuven
Leuven, Belgium
UMC Utrecht
Utrecht, Netherlands
Side branch angiographic Late Lumen Loss (expressed in millimeters) measured by Quantitative Coronary Analysis (QCA)
Time frame: 6 months
Target vessel failure (TVF)
Time frame: 6 months
Major Angiographic coronary or cerebral Events (MACCE)
Time frame: 6 months
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Paclitaxel eluting stent