POLish Bifurcation Optimal Stenting Study

NCT02192840 | Completed Phase 4 DMC

• 1 other identifier: 2.0
• Study Type: interventional
• Target: 243
• Locations: 1 country
• Sites: 1

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).

Conditions

Coronary Artery Disease

Keywords

provisional T stenting; dedicated bifurcation stent

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

• cardiac death

  12 months

• all-cause death

  12 months

• Target lesion revascularization

  12 months

• Target vessel revascularization

  12 months

• myocardial infarction

  12 months

Study Arms (2)

rDES Group

ACTIVE COMPARATOR

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)

Procedure: Coronary angioplasty with stent implantation

BiOSS Group

EXPERIMENTAL

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

Procedure: Coronary angioplasty with stent implantation

Interventions

Coronary angioplasty with stent implantation PROCEDURE

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

Also known as: 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)

BiOSS Group; rDES Group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:

• 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

Sponsors & Collaborators

• Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland: lead
• University National Heart Hospital: collaborator

Study Sites (1)

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

Warsaw, Poland

Location

Related Publications (6)

• 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.

  PMID: 16226167 BACKGROUND

• 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.

  PMID: 18973506 BACKGROUND

• 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.

  PMID: 19702678 BACKGROUND

• 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.

  PMID: 20642477 BACKGROUND

• 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.

  PMID: 22829507 BACKGROUND

• 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.

  PMID: 33782985 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Angioplasty, Balloon; Biosensing Techniques

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Angioplasty; Catheterization; Therapeutics; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques; Molecular Probe Techniques

Study Officials

• Robert J Gil, MD, PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: July 14, 2014
• First Posted: July 17, 2014
• Study Start: October 1, 2010
• Primary Completion: January 1, 2013
• Study Completion: March 1, 2013
• Last Updated: July 17, 2014

Record last verified: 2014-07

Locations

PL (1)