DES Versus BiOSS LIM - POLBOS II Study (POLBOS II)

July 28, 2015 updated by: Jacek Bil, Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland

Regular Drug Eluting Stent Versus Dedicated Bifurcation Sirolimus-eluting Stent BiOSS LIM in Coronary Bifurcation Treatment - Randomized POLBOS II Study.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

After signing the informed consent patients were randomly assigned to one of two treatment strategies: BiOSS LIM® stent implantation or rDES implantation (envelope randomization, 1:1). If the patient was enrolled to rDES Group there was a second randomization: with or without final kissing ballooning (FKB). Clinical follow-up was performed with office visits or telephone contacts at 1 and 12 months after intervention. Adverse events were monitored throughout the study period. Follow-up coronary angiography was performed at 12 months unless clinically indicated earlier.

Study Type

Interventional

Enrollment (Actual)

202

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
    • Mazowieckie
      • Warsaw, Mazowieckie, Poland, 02-507
        • Central Clinical Hospital of the Ministry of Interior

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • stable coronary artery disease (CAD) or non-ST-segment elevation acute coronary syndrome (NSTE-ACS)
  • age ≥ 18 years old,
  • de novo coronary bifurcation lesion (including unprotected LMS),
  • MV diameter ≥ 2.5 mm and SB diameter ≥ 2.0 mm assessed by visual estimation.

Exclusion Criteria:

  • ST-elevation myocardial infarction (STEMI),
  • bifurcations with Medina type 0,0,1,
  • serum creatinine level ≥ 2.0 mg/dl,
  • inability to take dual antiplatelet therapy for 12 months,
  • left ejection fraction ≤ 30%
  • lack of an informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: rDES Group
regular drug-eluting stent implantation in coronary lesion within bifurcation LucChopin Xience Promus Resolute Integrity Biomatrix Prolim
Procedure: Coronary angioplasty with stent implantation
Other Names:
  • device: LucChopin (Balton, Poland)
  • device: Xience (Abbot Vascular)
  • device: Promus (Boston Scientific)
  • device: Resolute Integrity (Medtronic)
  • device: Biomatrix (Biosensors)
  • device: Prolim (Balton, Poland)
Drug: Dual antipletlet therapy (DAPT)
DAPT given to each patient before stent implantation
Other Names:
  • clopidogrel
  • acetysalicylic acid
Experimental: BiOSS LIM Group
BiOSS LIM® stent implantation into coronary lesion within bifurcation.
Procedure: Coronary angioplasty with stent implantation
Other Names:
  • device: LucChopin (Balton, Poland)
  • device: Xience (Abbot Vascular)
  • device: Promus (Boston Scientific)
  • device: Resolute Integrity (Medtronic)
  • device: Biomatrix (Biosensors)
  • device: Prolim (Balton, Poland)
Drug: Dual antipletlet therapy (DAPT)
DAPT given to each patient before stent implantation
Other Names:
  • clopidogrel
  • acetysalicylic acid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MACE
Time Frame: 12 months
Cumulative rate of major adverse cardiovascular events (MACE) including cardiac death, myocardial infarction (MI) and repeated revascularization of the target lesion (TLR)
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cardiac death
Time Frame: 12 months
12 months
all-cause death
Time Frame: 12 months
12 months
MI
Time Frame: 12 months
myocardial infarction
12 months
TLR
Time Frame: 12 months
target lesion revascularization
12 months
TVR
Time Frame: 12 months
target vessel revascularization
12 months
LLL
Time Frame: 12 months
late lumen loss
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

July 20, 2014

First Submitted That Met QC Criteria

July 21, 2014

First Posted (Estimate)

July 23, 2014

Study Record Updates

Last Update Posted (Estimate)

July 30, 2015

Last Update Submitted That Met QC Criteria

July 28, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2.1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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