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Coronary Artery DiseasePhase 4POLBOS 3NCT03548272

BiOSS LIM C vs 2nd Generation DES in Non-LM Bifurcations

A Phase 4 study testing Percutaneous Coronary Intervention with stent implantation 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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Coronary bifurcations are encountered in about 15 - 20% of percutaneous coronary interventions (PCI). They are considered technically challenging and associated with worse clinical outcomes than non-bifurcation lesions. Percutaneous coronary intervention (PCI) to the target bifurcation lesion. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Artery Disease
What is being tested?
Percutaneous Coronary Intervention with stent implantation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
518 participants
Where
1 sitePoland
Study dates
12 Jun 2018to Jun 2020
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subject at least 18 years of age.
  • 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.

Who cannot join

  • 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
  • Distal LM stenosis

Trial locations and contacts

1 site in 1 country.

Poland1 site, 1 recruiting

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

    Warsaw

    Robert J Gil, MD, PhD, FESC, +48225081100, robert.gil@cskmswia.pl

    Robert J Gil, MD, PhD, FESC

    Recruiting

Other trials in Poland

About this study

Official title: POLish Bifurcation Optimal Treatment Strategy (POLBOS 3) Randomized Study

Coronary bifurcations are encountered in about 15 - 20% of percutaneous coronary interventions (PCI). They are considered technically challenging and associated with worse clinical outcomes than non-bifurcation lesions. Percutaneous coronary intervention (PCI) to the target bifurcation lesion. Randomization (by means envelope randomization) to investigational device: Group 1 for BiOSS LIM C implantation vs Group 2 for any DES implantation.

Read the detailed description

Single stent implantation in the main vessel-main branch across a side branch is the default strategy (provisional T-stenting, PTS) in all patients enrolled. Bifurcation lesions are assessed according to Medina classification using an index of 1 for stenosis greater than 50% and 0 for no stenosis (visual estimation). There is no restriction regarding lesion length in patient selection. If required, additional stent can be implanted (Alex Plus in the BiOSS Lim C Group). A stent in a side branch (Alex Plus in the BiOSS Lim C Group) should be implanted only if there is proximal residual stenosis greater than 70% after balloon dilatation and/or significant flow impairment after main vessel - main branch stenting and/or a flow limiting dissection.

The implantation protocol for bifurcation is as follows:

  1. wiring of both branches;
  2. main vessel predilatation and/or side branch predilatation according to the operator's decision;
  3. stent implantation (inflation for at least 20 s);
  4. proximal optimization technique (POT)
  5. side branch postdilatation/side branch stent implantation if necessary
  6. final kissing balloon inflation at operator's discretion.
  7. Second proximal optimization technique (re-POT)
Being tested
Percutaneous Coronary Intervention with stent implantation
Keywords
dedicated bifurcation stent, non-LM bifurcation, 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.

  • Percutaneous Coronary Intervention with stent implantationProcedure or surgery

    PCI with BiOSS LIM C or rDES depending on the randomization

Study groups in NCT03548272
Study groupRoleWhat they receive
BiOSS LIM CExperimentalIntervention: Percutaneous coronary intervention (PCI) with BiOSS LIM C stent implantation. The BiOSS LIM C® is a dedicated bifurcation balloon expandable stent made of cobalt-chromium alloy (strut thickness 70 µm) releasing sirolimus (1.4 µg/mm2) from the surface of a biodegradable coating comprised of a copolymer of lactic and glycolic acids (PGLA). The degradation of the polymer lasts approximately 8 weeks. The BiOSS LIM C® stent consists of two main separate parts with different diameters: wider proximally, and distally smaller. The proximal part is always a bit shorter than the distal one (avg. 1 mm).
Receives: Procedure: Percutaneous Coronary Intervention with stent implantation
regular 2nd generation DESActive comparatorIntervention: Percutaneous coronary intervention (PCI) with regular drug-eluting stent implantation (rDES). rDES well-tested and available on the market. Xience, Orsiro, Resulte Integrity
Receives: Procedure: Percutaneous Coronary Intervention with stent implantation

What is being measured

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

  1. MACE

    Major Cardiovascular Events rate (cardiac death, myocardial infarction, target lesion revascularization);

    Measured: 12 months

Secondary outcomes (4)

  1. All cause death

    All cause death

    Measured: 12 months

  2. cardiac death

    cardiac death

    Measured: 12 months

  3. myocardial infarction

    myocardial infarction

    Measured: 12 months

  4. target lesion revascularization

    target lesion revascularization

    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 posted7 Jun 2018
  2. Study start12 Jun 2018
  3. Primary completionJun 2019 (estimated)
  4. Study completionJun 2020 (estimated)

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
Single blind
Who is masked
Outcomes assessor
Enrolment
518 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03548272
Sponsor's protocol ID
1.00
Acronym
POLBOS 3
Status last verified
Jul 2018
First submitted
24 May 2018
Last updated
19 Jul 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 1. Latib A, Colombo A, Sangiorgi GM. Bifurcation stenting: current strategies and new devices. Heart. 2009; 95(6): 495-504. 2. Lassen JF, Holm NR, Stankovic G, et al. Percutaneous coronary intervention for coronary bifurcation disease: consensus from the first 10 years of the European Bifurcation Club meetings. EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology. 2014; 10(5): 545-560. 3. Collet C, Costa RA, Abizaid A. Dedicated bifurcation analysis: dedicated devices. The international journal of cardiovascular imaging. 2011; 27(2): 181-188. 4. Gil RJ, Vassilev D, Michalek A, et al. 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; 8(3): 316-324. 5. Bil J, Gil RJ, Vassilev D, et al. Dedicated bifurcation paclitaxel-eluting stent BiOSS Expert(R) in the treatment of distal left main stem stenosis. J Interv Cardiol. 2014; 27(3): 242-251. 6. Vassilev D, Gil R, Milewski K. Bifurcation Optimisation Stent System (BiOSS Lim) with sirolimus elution: results from porcine coronary artery model. EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology. 2011; 7(5): 614-620. 7. Gil RJ, Bil J, Michalek A, et al. 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; 29(8): 1667-1676. 8. Gil R, Bil J, Džavík V, et al. Regular drug-eluting stent versus dedicated coronary bifurcation BiOSS Expert® stent - randomized, multicenter, open-label, controlled POLBOS I trial. Can J Cardiol. 2015; http://dx.doi.org/10.1016/j.cjca.2014.12.024( 9. Gil R, Bil J, Grundeken M, et al. Long-term effectiveness and safety of the sirolimus-eluting BiOSS LIM® dedicated bifurcation stent in the treatment of distal left main stenosis: an international registry. (EuroIntervention - uder review). 2015; 10. Gil RJ, Bil J, Vassiliev D, et al. First-in-man study of dedicated bifurcation sirolimus-eluting stent: 12-month results of BiOSS LIM(R) Registry. J Interv Cardiol. 2015; 28(1): 51-60. 11. Bil J, Gil RJ, Pawlowski T, et al. Assessment of vascular response to BiOSS LIM C(R) stents vs Orsiro(R) stents in the porcine coronary artery model. Cardiovasc Ther. 2017; 12. Medina A, Suarez de Lezo J, Pan M. [A new classification of coronary bifurcation lesions]. Revista espanola de cardiologia. 2006; 59(2): 183. 13. Legutko J, Gil RJ, Buszman P, et al. OCT evaluation of the time course of vessel healing following implantation of new generation biodegradable polymer-coated and sirolimus-eluting cobalt-chromium coronary stent system (ALEX OCT Study). JACC. 2013; 62(18 (S1)): B170-B171. 14. Thygesen K, Alpert JS, Jaffe AS, et al. Third universal definition of myocardial infarction. Circulation. 2012; 126(16): 2020-2035.

  • Gil RJ, Kern A, Bojko K, Gziut-Rudkowska A, Vassilev D, Bil J. The Randomized, Multicenter, Open-Label, Controlled POLBOS 3 Trial Comparing Regular Drug-Eluting Stents and the Sirolimus-Eluting BiOSS LIM C Dedicated Coronary Bifurcation Stent: Four-Year Results. Biomedicines. 2024 Apr 23;12(5):938. doi: 10.3390/biomedicines12050938.

    PubMed 38790900

  • Gil RJ, Pawlowski T, Legutko J, Lesiak M, Witkowski A, Gasior M, Kern A, Bil J. Rationale and design of the randomized, multicenter, open-label, controlled POLBOS 3 trial aimed to compare regular drug-eluting stents versus the dedicated coronary bifurcation sirolimus-eluting BiOSS LIM C stent. Medicine (Baltimore). 2019 Apr;98(14):e15106. doi: 10.1097/MD.0000000000015106.

    PubMed 30946377

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Percutaneous Coronary Intervention with stent implantation 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 5 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: status not confirmed, as of the sponsor's last update on 19 Jul 2018. 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?

Results are not available in the source record.

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

Each site lists its own contact: choose the nearest one under Trial locations. 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 NCT03548272, which also lists 3 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 19 Jul 2018.

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