DES Versus BiOSS LIM - POLBOS II Study

• Status: Completed
• Trial end date: 2015-03-01
• Target enrollment: 0
• Participant gender: All

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. Provisional T-stenting (PTS) is the best treatment strategy at the moment. However, 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. POLBOS II study is continuation of POLBOS I (POLish Bifurcation Optimal Stenting) study, in which paclitaxel-eluting stent BiOSS Expert® (Balton, Poland) was assessed. Now performance of sirolimus-eluting stent BiOSS LIM® (Balton, Poland) is verified.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland
• Treatments: Clopidogrel; Sirolimus

Criteria

Inclusion Criteria:

• stable coronary artery disease (CAD) or non-ST-segment elevation acute coronary syndrome (NSTE-ACS)

• age ≥ 18 years old,

• de novo coronary bifurcation lesion (including unprotected LMS),

• MV diameter ≥ 2.5 mm and SB diameter ≥ 2.0 mm assessed by visual estimation.

Exclusion Criteria:

• ST-elevation myocardial infarction (STEMI),

• bifurcations with Medina type 0,0,1,

• serum creatinine level ≥ 2.0 mg/dl,

• inability to take dual antiplatelet therapy for 12 months,

• left ejection fraction ≤ 30%

• lack of an informed consent