DES Versus BiOSS LIM - POLBOS II Study (POLBOS II)
Primary Purpose
Coronary Artery Disease
Status
Completed
Phase
Phase 4
Locations
Poland
Study Type
Interventional
Intervention
Coronary angioplasty with stent implantation
Dual antipletlet therapy (DAPT)
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease focused on measuring dedicated bifurcation stent, sirolimus eluting stent
Eligibility 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
Sites / Locations
- Central Clinical Hospital of the Ministry of Interior
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
rDES Group
BiOSS LIM Group
Arm Description
regular drug-eluting stent implantation in coronary lesion within bifurcation LucChopin Xience Promus Resolute Integrity Biomatrix Prolim
BiOSS LIM® stent implantation into coronary lesion within bifurcation.
Outcomes
Primary Outcome Measures
MACE
Cumulative rate of major adverse cardiovascular events (MACE) including cardiac death, myocardial infarction (MI) and repeated revascularization of the target lesion (TLR)
Secondary Outcome Measures
cardiac death
all-cause death
MI
myocardial infarction
TLR
target lesion revascularization
TVR
target vessel revascularization
LLL
late lumen loss
Full Information
NCT ID
NCT02198300
First Posted
July 20, 2014
Last Updated
July 28, 2015
Sponsor
Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland
1. Study Identification
Unique Protocol Identification Number
NCT02198300
Brief Title
DES Versus BiOSS LIM - POLBOS II Study
Acronym
POLBOS II
Official Title
Regular Drug Eluting Stent Versus Dedicated Bifurcation Sirolimus-eluting Stent BiOSS LIM in Coronary Bifurcation Treatment - Randomized POLBOS II Study.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
March 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
dedicated bifurcation stent, sirolimus eluting stent
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
202 (Actual)
8. Arms, Groups, and Interventions
Arm Title
rDES Group
Arm Type
Active Comparator
Arm Description
regular drug-eluting stent implantation in coronary lesion within bifurcation LucChopin Xience Promus Resolute Integrity Biomatrix Prolim
Arm Title
BiOSS LIM Group
Arm Type
Experimental
Arm Description
BiOSS LIM® stent implantation into coronary lesion within bifurcation.
Intervention Type
Procedure
Intervention Name(s)
Coronary angioplasty with stent implantation
Other Intervention Name(s)
device: LucChopin (Balton, Poland), device: Xience (Abbot Vascular), device: Promus (Boston Scientific), device: Resolute Integrity (Medtronic), device: Biomatrix (Biosensors), device: Prolim (Balton, Poland)
Intervention Type
Drug
Intervention Name(s)
Dual antipletlet therapy (DAPT)
Other Intervention Name(s)
acetysalicylic acid, clopidogrel
Intervention Description
DAPT given to each patient before stent implantation
Primary Outcome Measure Information:
Title
MACE
Description
Cumulative rate of major adverse cardiovascular events (MACE) including cardiac death, myocardial infarction (MI) and repeated revascularization of the target lesion (TLR)
Time Frame
12 months
Secondary Outcome Measure Information:
Title
cardiac death
Time Frame
12 months
Title
all-cause death
Time Frame
12 months
Title
MI
Description
myocardial infarction
Time Frame
12 months
Title
TLR
Description
target lesion revascularization
Time Frame
12 months
Title
TVR
Description
target vessel revascularization
Time Frame
12 months
Title
LLL
Description
late lumen loss
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert J Gil, MD, PhD
Organizational Affiliation
Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Central Clinical Hospital of the Ministry of Interior
City
Warsaw
State/Province
Mazowieckie
ZIP/Postal Code
02-507
Country
Poland
12. IPD Sharing Statement
Citations:
PubMed Identifier
24708143
Citation
Bil J, Gil RJ, Vassilev D, Rzezak J, Kulawik T, Pawlowski T. Dedicated bifurcation paclitaxel-eluting stent BiOSS Expert(R) in the treatment of distal left main stem stenosis. J Interv Cardiol. 2014 Jun;27(3):242-51. doi: 10.1111/joic.12119. Epub 2014 Apr 7.
Results Reference
background
PubMed Identifier
24157310
Citation
Vassilev D, Mateev H, Alexandrov A, Stankev M, Rigatelli G, Gil RJ. Stenting below-the-knee bifurcations with dedicated bifurcation stent BiOSS Lim - first in man case report. Cardiovasc Revasc Med. 2014 Apr;15(3):171-7. doi: 10.1016/j.carrev.2013.09.005. Epub 2013 Oct 22.
Results Reference
background
PubMed Identifier
23868287
Citation
Gil RJ, Bil J, Michalek A, Vassiliev D, Costa RA. Comparative analysis of lumen enlargement mechanisms achieved with the bifurcation dedicated BiOSS) stent versus classical coronary stent implantations by means of provisional side branch stenting strategy: an intravascular ultrasound study. Int J Cardiovasc Imaging. 2013 Dec;29(8):1667-76. doi: 10.1007/s10554-013-0264-0. Epub 2013 Jul 19.
Results Reference
background
PubMed Identifier
22829507
Citation
Gil RJ, Vassilev D, Michalek A, Kern A, Formuszewicz R, Dobrzycki S, Wojcik J, Lesiak M, Kardaszewicz P, Lekston A. Dedicated paclitaxel-eluting bifurcation stent BiOSS(R) (bifurcation optimisation stent system): 12-month results from a prospective registry of consecutive all-comers population. EuroIntervention. 2012 Jul 20;8(3):316-24. doi: 10.4244/EIJV8I3A50.
Results Reference
background
PubMed Identifier
21930466
Citation
Vassilev D, Gil R, Milewski K. Bifurcation Optimisation Stent System (BiOSS Lim) with sirolimus elution: results from porcine coronary artery model. EuroIntervention. 2011 Sep;7(5):614-20. doi: 10.4244/EIJV7I5A98.
Results Reference
background
PubMed Identifier
33782985
Citation
Gil RJ, Kern A, Formuszewicz R, Inigo Garcia LA, Dobrzycki S, Vassilev D, Bil J. 6-year results of BiOSS stents in coronary bifurcation treatment. Eur J Clin Invest. 2021 Aug;51(8):e13555. doi: 10.1111/eci.13555. Epub 2021 Mar 29.
Results Reference
derived
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DES Versus BiOSS LIM - POLBOS II Study
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