POLish Bifurcation Optimal Stenting Study (POLBOS)

This study has been completed.
Sponsor:
Collaborator:
University National Heart Hospital
Information provided by (Responsible Party):
Jacek Bil, Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland
ClinicalTrials.gov Identifier:
NCT02192840
First received: July 14, 2014
Last updated: July 15, 2014
Last verified: July 2014
  Purpose

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).


Condition Intervention Phase
Coronary Artery Disease
Procedure: Coronary angioplasty with stent implantation
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Regular DES Versus BiOSS Expert® Stent in Coronary Bifurcation Treatment - Randomized, Multicenter, Open-label, Controlled POLBOS I (POLish Bifurcation Optimal Stenting) Study

Resource links provided by NLM:


Further study details as provided by Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland:

Primary Outcome Measures:
  • MACE [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Cumulative rate of major adverse cardiovascular events (MACE) including cardiac death, myocardial infarction (MI) with or without ST-segment elevation and need for repeated revascularization of the target lesion (TLR).


Secondary Outcome Measures:
  • cardiac death [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • all-cause death [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Target lesion revascularization [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Target vessel revascularization [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • myocardial infarction [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • late lumen loss [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 243
Study Start Date: October 2010
Study Completion Date: March 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: rDES Group

Regular drug-eluting stent implantation, one of the following:

Device: LucChopin (Balton, Poland) Device: Prolim (Balton, Poland) Device: Xience Pro (Abott Vascular) Device: Biomatrix (Biosensors) Device: Promus (Boston Scientific) Device: Cypher (Cordis) Device: Taxus (Boston Scientific) Device: Coroflex Please (BBraun) Device: Resolute Integrity (Medtronic)

Procedure: Coronary angioplasty with stent implantation
Coronary angioplasty in bifurcation lesion with drug-eluting stent implantation: BiOSS or regular DES (rDES)
Other Names:
  • Device: LucChopin (Balton, Poland)
  • Device: Prolim (Balton, Poland)
  • Device: Xience Pro (Abott Vascular)
  • Device: Biomatrix (Biosensors)
  • Device: Promus (Boston Scientific)
  • Device: Cypher (Cordis)
  • Device: Taxus (Boston Scientific)
  • Device: Coroflex Please (BBraun)
  • Device: Resolute Integrity (Medtronic)
Experimental: BiOSS Group
New dedicated bifurcation stent BiOSS Expert (Balton, Warsaw, Poland) implantation
Procedure: Coronary angioplasty with stent implantation
Coronary angioplasty in bifurcation lesion with drug-eluting stent implantation: BiOSS or regular DES (rDES)
Other Names:
  • Device: LucChopin (Balton, Poland)
  • Device: Prolim (Balton, Poland)
  • Device: Xience Pro (Abott Vascular)
  • Device: Biomatrix (Biosensors)
  • Device: Promus (Boston Scientific)
  • Device: Cypher (Cordis)
  • Device: Taxus (Boston Scientific)
  • Device: Coroflex Please (BBraun)
  • Device: Resolute Integrity (Medtronic)

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject able to verbally confirm understandings of risks, benefits of receiving PCI for true bifurcation lesions, and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure.
  • Target main branch lesion(s) located in a native coronary artery with diameter of ≥ 2.5 mm and ≤ 4.5 mm. Target side branch lesion(s) located in a native coronary artery with diameter of ≥ 2.0 mm.
  • Target lesion(s) amenable for PCI with balloon angioplasty of the side branch.

Exclusion Criteria:

  • STEMI
  • Non-cardiac co-morbid conditions are present with life expectancy <1 year or that may result in protocol non-compliance (per site investigator's medical judgment).
  • Subjects who refuse to give informed consent.
  • Subjects with LVEF<30%
  • Subjects with moderate or severe degree valvular heart disease or primary cardiomyopathy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02192840

Locations
Poland
Department of Invasive Cardiology Central Clinical Hospital of the Ministry of Interior
Warsaw, Poland
Sponsors and Collaborators
Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland
University National Heart Hospital
Investigators
Principal Investigator: Robert J Gil, MD, PhD Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland
  More Information

Publications:
Responsible Party: Jacek Bil, MD, PhD, Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland
ClinicalTrials.gov Identifier: NCT02192840     History of Changes
Other Study ID Numbers: 2.0
Study First Received: July 14, 2014
Last Updated: July 15, 2014
Health Authority: Poland: Ministry of Health

Keywords provided by Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland:
provisional T stenting
dedicated bifurcation stent

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on September 11, 2014