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DES Versus BiOSS LIM - POLBOS II Study

NCT02198300 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 202

Last updated 2015-07-30

No results posted yet for this study

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. Provisional T-stenting (PTS) is the best treatment strategy at the moment. However, 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. POLBOS II study is continuation of POLBOS I (POLish Bifurcation Optimal Stenting) study, in which paclitaxel-eluting stent BiOSS Expert® (Balton, Poland) was assessed. Now performance of sirolimus-eluting stent BiOSS LIM® (Balton, Poland) is verified.

Conditions

Interventions

PROCEDURE

Coronary angioplasty with stent implantation

DRUG

Dual antipletlet therapy (DAPT)

DAPT given to each patient before stent implantation

Sponsors & Collaborators

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

    lead OTHER

Principal Investigators

  • Robert J Gil, MD, PhD · Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-11-30
Primary Completion
2014-12-31
Completion
2015-03-31

Countries

  • Poland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02198300 on ClinicalTrials.gov