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POLish Bifurcation Optimal Stenting Study (POLBOS)

Primary Purpose

Coronary Artery Disease

Status

Completed

Phase

Phase 4

Locations

Poland

Study Type

Interventional

Intervention

Coronary angioplasty with stent implantation

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring provisional T stenting, dedicated bifurcation stent

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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:

STEMI
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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

rDES Group

BiOSS Group

Arm Description

Regular drug-eluting stent implantation, one of the following: Device: LucChopin (Balton, Poland) Device: Prolim (Balton, Poland) Device: Xience Pro (Abott Vascular) Device: Biomatrix (Biosensors) Device: Promus (Boston Scientific) Device: Cypher (Cordis) Device: Taxus (Boston Scientific) Device: Coroflex Please (BBraun) Device: Resolute Integrity (Medtronic)

New dedicated bifurcation stent BiOSS Expert (Balton, Warsaw, Poland) implantation

Outcomes

Primary Outcome Measures

MACE

Cumulative rate of major adverse cardiovascular events (MACE) including cardiac death, myocardial infarction (MI) with or without ST-segment elevation and need for repeated revascularization of the target lesion (TLR).

Secondary Outcome Measures

cardiac death

all-cause death

Target lesion revascularization

Target vessel revascularization

myocardial infarction

late lumen loss

Full Information

NCT ID

NCT02192840

First Posted

July 14, 2014

Last Updated

July 15, 2014

Sponsor

Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland

Collaborators

University National Heart Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02192840

Brief Title

POLish Bifurcation Optimal Stenting Study

Acronym

POLBOS

Official Title

Regular DES Versus BiOSS Expert® Stent in Coronary Bifurcation Treatment - Randomized, Multicenter, Open-label, Controlled POLBOS I (POLish Bifurcation Optimal Stenting) Study

Study Type

Interventional

2. Study Status

Record Verification Date

July 2014

Overall Recruitment Status

Completed

Study Start Date

October 2010 (undefined)

Primary Completion Date

January 2013 (Actual)

Study Completion Date

March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland

Collaborators

University National Heart Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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. Therefore 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. The aim of POLBOS I (POLish Bifurcation Optimal Stenting) study was to compare two intervention strategies for bifurcation treatment: provisional T-stenting (PTS) with any regular drug-eluting stent (rDES), the best treatment strategy at the moment, with stenting of bifurcation lesions with dedicated bifurcation paclitaxel-eluting stent BiOSS Expert® (Balton, PL).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronary Artery Disease

Keywords

provisional T stenting, dedicated bifurcation stent

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

243 (Actual)

8. Arms, Groups, and Interventions

Arm Title

rDES Group

Arm Type

Active Comparator

Arm Description

Arm Title

BiOSS Group

Arm Type

Experimental

Arm Description

New dedicated bifurcation stent BiOSS Expert (Balton, Warsaw, Poland) implantation

Intervention Type

Procedure

Intervention Name(s)

Coronary angioplasty with stent implantation

Other Intervention Name(s)

Device: LucChopin (Balton, Poland), Device: Prolim (Balton, Poland), Device: Xience Pro (Abott Vascular), Device: Biomatrix (Biosensors), Device: Promus (Boston Scientific), Device: Cypher (Cordis), Device: Taxus (Boston Scientific), Device: Coroflex Please (BBraun), Device: Resolute Integrity (Medtronic)

Intervention Description

Coronary angioplasty in bifurcation lesion with drug-eluting stent implantation: BiOSS or regular DES (rDES)

Primary Outcome Measure Information:

Title

MACE

Description

Time Frame

12 months

Secondary Outcome Measure Information:

Title

cardiac death

Time Frame

12 months

Title

all-cause death

Time Frame

12 months

Title

Target lesion revascularization

Time Frame

12 months

Title

Target vessel revascularization

Time Frame

12 months

Title

myocardial infarction

Time Frame

12 months

Title

late lumen loss

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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: STEMI 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Robert J Gil, MD, PhD

Organizational Affiliation

Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Warsaw

Country

Poland

12. IPD Sharing Statement

Citations:

PubMed Identifier

16226167

Citation

Iakovou I, Ge L, Colombo A. Contemporary stent treatment of coronary bifurcations. J Am Coll Cardiol. 2005 Oct 18;46(8):1446-55. doi: 10.1016/j.jacc.2005.05.080. Epub 2005 Sep 28.

Results Reference

background

PubMed Identifier

18973506

Citation

Vassilev D, Gil R. Clinical verification of a theory for predicting side branch stenosis after main vessel stenting in coronary bifurcation lesions. J Interv Cardiol. 2008 Dec;21(6):493-503. doi: 10.1111/j.1540-8183.2008.00400.x. Epub 2008 Oct 21.

Results Reference

background

PubMed Identifier

19702678

Citation

Gil RJ, Vassilev D, Formuszewicz R, Rusicka-Piekarz T, Doganov A. The carina angle-new geometrical parameter associated with periprocedural side branch compromise and the long-term results in coronary bifurcation lesions with main vessel stenting only. J Interv Cardiol. 2009 Dec;22(6):E1-E10. doi: 10.1111/j.1540-8183.2009.00492.x. Epub 2009 Aug 20.

Results Reference

background

PubMed Identifier

20642477

Citation

Vassilev D, Gil R, Kwan T, Nguyen T, Nanjundappa A, Doganov A. Extension distance mismatch--an unrecognized factor for suboptimal side branch ostial coverage in bifurcation lesion stenting. J Interv Cardiol. 2010 Aug;23(4):305-18. doi: 10.1111/j.1540-8183.2010.00574.x. Epub 2010 Jul 19.

Results Reference

background

PubMed Identifier

22829507

Citation

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.

Results Reference

background

PubMed Identifier

33782985

Citation

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.

Results Reference

derived

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POLish Bifurcation Optimal Stenting Study

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