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BiOSS LIM C vs 2nd Generation DES in Non-LM Bifurcations (POLBOS 3)

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ClinicalTrials.gov Identifier: NCT03548272
Recruitment Status : Recruiting
First Posted : June 7, 2018
Last Update Posted : July 19, 2018
Sponsor:
Information provided by (Responsible Party):
Jacek Bil, Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland

Brief 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. Randomization (by means envelope randomization) to investigational device: Group 1 for BiOSS LIM C implantation vs Group 2 for any DES implantation.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Procedure: Percutaneous Coronary Intervention with stent implantation Phase 4

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)

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 518 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: POLish Bifurcation Optimal Treatment Strategy (POLBOS 3) Randomized Study
Actual Study Start Date : June 12, 2018
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2020

Arm Intervention/treatment
Experimental: BiOSS LIM C

Intervention: 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).

Procedure: Percutaneous Coronary Intervention with stent implantation
PCI with BiOSS LIM C or rDES depending on the randomization

Active Comparator: regular 2nd generation DES

Intervention: Percutaneous coronary intervention (PCI) with regular drug-eluting stent implantation (rDES).

rDES well-tested and available on the market. Xience, Orsiro, Resulte Integrity

Procedure: Percutaneous Coronary Intervention with stent implantation
PCI with BiOSS LIM C or rDES depending on the randomization




Primary Outcome Measures :
  1. MACE [ Time Frame: 12 months ]
    Major Cardiovascular Events rate (cardiac death, myocardial infarction, target lesion revascularization);


Secondary Outcome Measures :
  1. All cause death [ Time Frame: 12 months ]
    All cause death

  2. cardiac death [ Time Frame: 12 months ]
    cardiac death

  3. myocardial infarction [ Time Frame: 12 months ]
    myocardial infarction

  4. target lesion revascularization [ Time Frame: 12 months ]
    target lesion revascularization



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subject at least 18 years of age.
  2. 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.
  3. 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.
  4. Target lesion(s) amenable for PCI with balloon angioplasty of the side branch.

Exclusion Criteria:

  1. 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).
  2. Subjects who refuse to give informed consent.
  3. Subjects with LVEF<30%
  4. Subjects with moderate or severe degree valvular heart disease or primary cardiomyopathy
  5. Distal LM stenosis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03548272


Locations
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Poland
Department of Invasive Cardiology Central Clinical Hospital of the Ministry of Interior Recruiting
Warsaw, Poland
Contact: Robert J Gil, MD, PhD, FESC    +48225081100    robert.gil@cskmswia.pl   
Principal Investigator: Robert J Gil, MD, PhD, FESC         
Sub-Investigator: Jacek Bil, MD, PhD         
Sponsors and Collaborators
Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland

Publications of Results:
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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jacek Bil, Principal Investigator, Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland
ClinicalTrials.gov Identifier: NCT03548272     History of Changes
Other Study ID Numbers: 1.00
First Posted: June 7, 2018    Key Record Dates
Last Update Posted: July 19, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jacek Bil, Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland:
dedicated bifurcation stent
non-LM bifurcation
sirolimus-eluting stent

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