NCT02198300

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
202

participants targeted

Target at P50-P75 for phase_4 coronary-artery-disease

Timeline
Completed

Started Nov 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

July 20, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 23, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

July 30, 2015

Status Verified

July 1, 2015

Enrollment Period

2.1 years

First QC Date

July 20, 2014

Last Update Submit

July 28, 2015

Conditions

Coronary Artery Disease

Keywords

dedicated bifurcation stentsirolimus eluting stent

Outcome Measures

Primary Outcomes (1)

  • MACE

    Cumulative rate of major adverse cardiovascular events (MACE) including cardiac death, myocardial infarction (MI) and repeated revascularization of the target lesion (TLR)

    12 months

Secondary Outcomes (6)

  • cardiac death

    12 months

  • all-cause death

    12 months

  • MI

    12 months

  • TLR

    12 months

  • TVR

    12 months

  • +1 more secondary outcomes

Study Arms (2)

rDES Group

ACTIVE COMPARATOR

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

Procedure: Coronary angioplasty with stent implantationDrug: Dual antipletlet therapy (DAPT)

BiOSS LIM Group

EXPERIMENTAL

BiOSS LIM® stent implantation into coronary lesion within bifurcation.

Procedure: Coronary angioplasty with stent implantationDrug: Dual antipletlet therapy (DAPT)

Interventions

Coronary angioplasty with stent implantationPROCEDURE
Also known as: device: LucChopin (Balton, Poland), device: Xience (Abbot Vascular), device: Promus (Boston Scientific), device: Resolute Integrity (Medtronic), device: Biomatrix (Biosensors), device: Prolim (Balton, Poland)
BiOSS LIM GrouprDES Group
Dual antipletlet therapy (DAPT)DRUG

DAPT given to each patient before stent implantation

Also known as: acetysalicylic acid, clopidogrel
BiOSS LIM GrouprDES Group

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Central Clinical Hospital of the Ministry of Interior

Warsaw, Masovian Voivodeship, 02-507, Poland

Location

Related Publications (6)

  • 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.

    PMID: 24708143BACKGROUND

  • 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.

    PMID: 24157310BACKGROUND

  • 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.

    PMID: 23868287BACKGROUND

  • 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.

    PMID: 22829507BACKGROUND

  • 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.

    PMID: 21930466BACKGROUND

  • 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.

    PMID: 33782985DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Angioplasty, BalloonBiosensing TechniquesClopidogrel

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

AngioplastyCatheterizationTherapeuticsEndovascular ProceduresVascular Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical ProceduresInvestigative TechniquesMolecular Probe TechniquesTiclopidineThienopyridinesThiophenesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Robert J Gil, MD, PhD

    Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

July 20, 2014

First Posted

July 23, 2014

Study Start

November 1, 2012

Primary Completion

December 1, 2014

Study Completion

March 1, 2015

Last Updated

July 30, 2015

Record last verified: 2015-07

Locations

PL(1)