- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03548272
BiOSS LIM C vs 2nd Generation DES in Non-LM Bifurcations (POLBOS 3)
POLish Bifurcation Optimal Treatment Strategy (POLBOS 3) Randomized Study
Study Overview
Status
Conditions
Intervention / Treatment
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:
- wiring of both branches;
- main vessel predilatation and/or side branch predilatation according to the operator's decision;
- stent implantation (inflation for at least 20 s);
- proximal optimization technique (POT)
- side branch postdilatation/side branch stent implantation if necessary
- final kissing balloon inflation at operator's discretion.
- Second proximal optimization technique (re-POT)
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
-
Warsaw, Poland
- Recruiting
- Department of Invasive Cardiology Central Clinical Hospital of the Ministry of Interior
-
Contact:
- Robert J Gil, MD, PhD, FESC
- Phone Number: +48225081100
- Email: robert.gil@cskmswia.pl
-
Principal Investigator:
- Robert J Gil, MD, PhD, FESC
-
Sub-Investigator:
- Jacek Bil, MD, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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). |
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 |
PCI with BiOSS LIM C or rDES depending on the randomization
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
MACE
Time Frame: 12 months
|
Major Cardiovascular Events rate (cardiac death, myocardial infarction, target lesion revascularization);
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
target lesion revascularization
Time Frame: 12 months
|
target lesion revascularization
|
12 months
|
All cause death
Time Frame: 12 months
|
All cause death
|
12 months
|
cardiac death
Time Frame: 12 months
|
cardiac death
|
12 months
|
myocardial infarction
Time Frame: 12 months
|
myocardial infarction
|
12 months
|
Collaborators and Investigators
Publications and helpful links
General 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, 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1.00
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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