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NCT Number: NCT02192840

POLish Bifurcation Optimal Stenting Study

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).

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Invasive Cardiology Central Clinical Hospital of the Ministry of Interior

Warsaw, Poland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Coronary angioplasty with stent implantation

Procedure

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)

Primary outcomes

  1. MACE

    Time frame: 12 months

    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 outcomes

  1. cardiac death

    Time frame: 12 months

  2. all-cause death

    Time frame: 12 months

  3. Target lesion revascularization

    Time frame: 12 months

  4. Target vessel revascularization

    Time frame: 12 months

  5. myocardial infarction

    Time frame: 12 months

  6. late lumen loss

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

  • University National Heart Hospital

Registry information

Official study title

Regular DES Versus BiOSS Expert® Stent in Coronary Bifurcation Treatment - Randomized, Multicenter, Open-label, Controlled POLBOS I (POLish Bifurcation Optimal Stenting) Study

Acronym: POLBOS

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Jul 17, 2014
Registry last updated
Jul 17, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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