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Coronary Artery DiseasePhase 4POLBOS IINCT02198300

DES Versus BiOSS LIM - POLBOS II Study

A Phase 4 study testing Coronary angioplasty with stent implantation and Dual antipletlet therapy (DAPT) in people with Coronary Artery Disease, run by Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland at 1 site in Poland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Coronary Artery Disease
What is being tested?
Coronary angioplasty with stent implantation and Dual antipletlet therapy (DAPT)
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
202 participants
Where
1 sitePoland
Study dates
Nov 2012to Mar 2015
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Poland1 site

  • Central Clinical Hospital of the Ministry of Interior

    Warsaw, Masovian Voivodeship, 02-507

Other trials in Poland

About this study

Official title: Regular Drug Eluting Stent Versus Dedicated Bifurcation Sirolimus-eluting Stent BiOSS LIM in Coronary Bifurcation Treatment - Randomized 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.

Read the 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.

Being tested
Coronary angioplasty with stent implantation, Dual antipletlet therapy (DAPT)
Keywords
dedicated bifurcation stent, sirolimus eluting stent
Medical subject headings
Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Coronary angioplasty with stent implantationProcedure or surgery

    Also called device: LucChopin (Balton, Poland), device: Xience (Abbot Vascular), device: Promus (Boston Scientific), device: Resolute Integrity (Medtronic)

  • Dual antipletlet therapy (DAPT)Drug

    Also called acetysalicylic acid, clopidogrel

    DAPT given to each patient before stent implantation

Study groups in NCT02198300
Study groupRoleWhat they receive
rDES GroupActive comparatorregular drug-eluting stent implantation in coronary lesion within bifurcation LucChopin Xience Promus Resolute Integrity Biomatrix Prolim
Receives: Procedure: Coronary angioplasty with stent implantation; Drug: Dual antipletlet therapy (DAPT)
BiOSS LIM GroupExperimentalBiOSS LIM® stent implantation into coronary lesion within bifurcation.
Receives: Procedure: Coronary angioplasty with stent implantation; Drug: Dual antipletlet therapy (DAPT)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. MACE

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

    Measured: 12 months

Secondary outcomes (6)

  1. cardiac death

    Measured: 12 months

  2. all-cause death

    Measured: 12 months

  3. MI

    myocardial infarction

    Measured: 12 months

  4. TLR

    target lesion revascularization

    Measured: 12 months

  5. TVR

    target vessel revascularization

    Measured: 12 months

  6. LLL

    late lumen loss

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jul 2014 (estimated)
  2. Study startNov 2012
  3. Primary completionDec 2014
  4. Study completionMar 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
202 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02198300
Sponsor's protocol ID
2.1
Acronym
POLBOS II
Status last verified
Jul 2015
First submitted
20 Jul 2014
Last updated
30 Jul 2015
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 24708143

  • 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.

    PubMed 24157310

  • 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.

    PubMed 23868287

  • 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.

    PubMed 22829507

  • 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.

    PubMed 21930466

  • 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.

    PubMed 33782985

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Coronary angioplasty with stent implantation and Dual antipletlet therapy (DAPT) in people with Coronary Artery Disease, run by Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland at 1 site in Poland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

MACE (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02198300, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2015.

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DES Versus BiOSS LIM - POLBOS II Study (NCT02198300) | AzTrials