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Completed

NCT Number: NCT02198300

DES Versus BiOSS LIM - POLBOS II 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. 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.

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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

Central Clinical Hospital of the Ministry of Interior

Warsaw, Masovian Voivodeship, 02-507, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Coronary angioplasty with stent implantation

Procedure

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)

Dual antipletlet therapy (DAPT)

Drug

DAPT given to each patient before stent implantation

Other names: acetysalicylic acid, clopidogrel

Primary outcomes

  1. MACE

    Time frame: 12 months

    Cumulative rate of major adverse cardiovascular events (MACE) including cardiac death, myocardial infarction (MI) and 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. MI

    Time frame: 12 months

    myocardial infarction

  4. TLR

    Time frame: 12 months

    target lesion revascularization

  5. TVR

    Time frame: 12 months

    target vessel revascularization

  6. LLL

    Time frame: 12 months

    late lumen loss

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Acronym: POLBOS II

Important dates

Study start
2012
Primary completion
2014
Study completion
2015
First posted
Jul 23, 2014
Registry last updated
Jul 30, 2015

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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