POLish Bifurcation Optimal Stenting Study

Coronary Artery Disease Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02192840
• Other study ID #: 2.0
• Status: Completed
• Phase: Phase 4
• First received: July 14, 2014
• Last updated: July 15, 2014
• Start date: October 2010
• Est. completion date: March 2013

Study information

• Verified date: July 2014
• Source: Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Ministry of Health
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 243
• Est. completion date: March 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

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

Locations

Country	Name	City	State
Poland	Department of Invasive Cardiology Central Clinical Hospital of the Ministry of Interior	Warsaw

Sponsors (2)

Lead Sponsor	Collaborator
Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland	University National Heart Hospital

Country where clinical trial is conducted

Poland, 

References & Publications (5)

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. — View Citation

Gil RJ, Vassilev D, Michalek A, Kern A, Formuszewicz R, Dobrzycki S, Wójcik J, Lesiak M, Kardaszewicz P, Lekston A. Dedicated paclitaxel-eluting bifurcation stent BiOSS® (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. — View Citation

Iakovou I, Ge L, Colombo A. Contemporary stent treatment of coronary bifurcations. J Am Coll Cardiol. 2005 Oct 18;46(8):1446-55. Epub 2005 Sep 28. Review. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	12 months	Yes
Secondary	cardiac death		12 months	Yes
Secondary	all-cause death		12 months	Yes
Secondary	Target lesion revascularization		12 months	No
Secondary	Target vessel revascularization		12 months	No
Secondary	myocardial infarction		12 months	Yes
Secondary	late lumen loss		12 months	No