NCT03548272

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
518

participants targeted

Target at P75+ for phase_4 coronary-artery-disease

Timeline
Completed

Started Jun 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 24, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 7, 2018

Completed
5 days until next milestone

Study Start

First participant enrolled

June 12, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
Last Updated

July 19, 2018

Status Verified

July 1, 2018

Enrollment Period

12 months

First QC Date

May 24, 2018

Last Update Submit

July 17, 2018

Conditions

Coronary Artery Disease

Keywords

dedicated bifurcation stentnon-LM bifurcationsirolimus-eluting stent

Outcome Measures

Primary Outcomes (1)

  • MACE

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

    12 months

Secondary Outcomes (4)

  • All cause death

    12 months

  • cardiac death

    12 months

  • myocardial infarction

    12 months

  • target lesion revascularization

    12 months

Study Arms (2)

BiOSS LIM C

EXPERIMENTAL

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

regular 2nd generation DES

ACTIVE COMPARATOR

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

Interventions

Percutaneous Coronary Intervention with stent implantationPROCEDURE

PCI with BiOSS LIM C or rDES depending on the randomization

BiOSS LIM Cregular 2nd generation DES

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Warsaw, Poland

RECRUITING

Related Publications (3)

  • 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.

    RESULT

  • 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.

    PMID: 38790900DERIVED

  • 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.

    PMID: 30946377DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Endovascular ProceduresVascular Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 24, 2018

First Posted

June 7, 2018

Study Start

June 12, 2018

Primary Completion

June 1, 2019

Study Completion

June 1, 2020

Last Updated

July 19, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share

Locations

PL(1)