Trial | NCT02198300  Report issue

Title

DES Versus BiOSS LIM - POLBOS II Study
Regular Drug Eluting Stent Versus Dedicated Bifurcation Sirolimus-eluting Stent BiOSS LIM in Coronary Bifurcation Treatment - Randomized POLBOS II Study.

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    202
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.
After signing the informed consent patients were randomly assigned to one of two treatment strategies: BiOSS LIM® stent implantation or rDES implantation (envelope randomization, 1:1). If the patient was enrolled to rDES Group there was a second randomization: with or without final kissing ballooning (FKB). Clinical follow-up was performed with office visits or telephone contacts at 1 and 12 months after intervention. Adverse events were monitored throughout the study period. Follow-up coronary angiography was performed at 12 months unless clinically indicated earlier.
Study Started
Nov 30
2012
Primary Completion
Dec 31
2014
Study Completion
Mar 31
2015
Last Update
Jul 30
2015
Estimate

Procedure Coronary angioplasty with stent implantation

  • Other names: device: LucChopin (Balton, Poland), device: Xience (Abbot Vascular), device: Promus (Boston Scientific), device: Resolute Integrity (Medtronic), device: Biomatrix (Biosensors), device: Prolim (Balton, Poland)

Drug Dual antipletlet therapy (DAPT)

DAPT given to each patient before stent implantation

  • Other names: acetysalicylic acid, clopidogrel

rDES Group Active Comparator

regular drug-eluting stent implantation in coronary lesion within bifurcation LucChopin Xience Promus Resolute Integrity Biomatrix Prolim

BiOSS LIM Group Experimental

BiOSS LIM® stent implantation into coronary lesion within bifurcation.

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
No Results Posted