Status:
COMPLETED
POLish Bifurcation Optimal Stenting Study
Lead Sponsor:
Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland
Collaborating Sponsors:
University National Heart Hospital
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18-90 years
Phase:
PHASE4
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
243 Patients enrolled
Trial Details
Trial ID
NCT02192840
Start Date
October 1 2010
End Date
March 1 2013
Last Update
July 17 2014
Active Locations (1)
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1
Department of Invasive Cardiology Central Clinical Hospital of the Ministry of Interior
Warsaw, Poland