POLish Bifurcation Optimal Stenting Study

Phase 4

Completed

• Conditions: Coronary Artery Disease
• Interventions: Procedure: Coronary angioplasty with stent implantation

• Registration Number: NCT02192840
• Lead Sponsor: Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10
• Primary Completion: 2013-01
• Study Completion: 2013-03
• Status Verified: 2014-07
• Study First Submitted: 2014-07-14
• Study First Submitted QC: 2014-07-15
• Last Update Submitted: 2014-07-15
• Study First Posted: 2014-07-17
• Last Update Posted: 2014-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 243

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
rDES Group	Coronary angioplasty with stent implantation	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)
BiOSS Group	Coronary angioplasty with stent implantation	New dedicated bifurcation stent BiOSS Expert (Balton, Warsaw, Poland) implantation

Primary Outcome Measures

Name	Time	Method
MACE	12 months	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

Name	Time	Method
late lumen loss	12 months
myocardial infarction	12 months
cardiac death	12 months
all-cause death	12 months
Target lesion revascularization	12 months
Target vessel revascularization	12 months

Trial Locations

Locations (1)

Department of Invasive Cardiology Central Clinical Hospital of the Ministry of Interior; 🇵🇱 Warsaw, Poland