NCT02192840

POLish Bifurcation Optimal Stenting Study

Regular DES Versus BiOSS Expert® Stent in Coronary Bifurcation Treatment - Randomized, Multicenter, Open-label, Controlled POLBOS I (POLish Bifurcation Optimal Stenting) Study

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 243 (actual)
• Sponsor: Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

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).

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
PROCEDURE	Coronary angioplasty with stent implantation	Coronary angioplasty in bifurcation lesion with drug-eluting stent implantation: BiOSS or regular DES (rDES)

Timeline

• Start date: 2010-10-01
• Primary completion: 2013-01-01
• Completion: 2013-03-01
• First posted: 2014-07-17
• Last updated: 2014-07-17

Locations

1 site across 1 country: Poland