Coronary Artery Disease Clinical Trial
Official title:
Regular DES Versus BiOSS Expert® Stent in Coronary Bifurcation Treatment - Randomized, Multicenter, Open-label, Controlled POLBOS I (POLish Bifurcation Optimal Stenting) Study
Coronary bifurcation lesions pose therapeutic problems during percutaneous coronary
interventions (PCI) and are associated with higher rates of periprocedural complications as
well as higher rates of in-stent restenosis and stent thrombosis. Therefore the optimal
approach to coronary bifurcations treatment is still a subject of debate, especially when
the side branch is large, not easily accessible and narrowed by a long lesion. One of the
proposed alternatives are dedicated bifurcation stents (DBS). However, there is large
scarcity of randomized trials with DBS.
The aim of POLBOS I (POLish Bifurcation Optimal Stenting) study was to compare two
intervention strategies for bifurcation treatment: provisional T-stenting (PTS) with any
regular drug-eluting stent (rDES), the best treatment strategy at the moment, with stenting
of bifurcation lesions with dedicated bifurcation paclitaxel-eluting stent BiOSS Expert®
(Balton, PL).
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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