Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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19 February 2015 |
Main ID: |
NCT02192840 |
Date of registration:
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14/07/2014 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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POLish Bifurcation Optimal Stenting Study
POLBOS |
Scientific title:
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Regular DES Versus BiOSS Expert® Stent in Coronary Bifurcation Treatment - Randomized, Multicenter, Open-label, Controlled POLBOS I (POLish Bifurcation Optimal Stenting) Study |
Date of first enrolment:
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October 2010 |
Target sample size:
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243 |
Recruitment status: |
Completed |
URL:
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http://clinicaltrials.gov/show/NCT02192840 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 4
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Countries of recruitment
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Poland
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Contacts
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Name:
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Robert J Gil, MD, PhD |
Address:
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Telephone:
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Email:
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Affiliation:
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Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
90 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Coronary Artery Disease
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Intervention(s)
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Procedure: Coronary angioplasty with stent implantation
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Primary Outcome(s)
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MACE
[Time Frame: 12 months]
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Secondary Outcome(s)
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Target vessel revascularization
[Time Frame: 12 months]
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all-cause death
[Time Frame: 12 months]
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myocardial infarction
[Time Frame: 12 months]
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Target lesion revascularization
[Time Frame: 12 months]
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cardiac death
[Time Frame: 12 months]
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late lumen loss
[Time Frame: 12 months]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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