Status:
COMPLETED
DES Versus BiOSS LIM - POLBOS II Study
Lead Sponsor:
Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland
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 ...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2015
Estimated Enrollment :
202 Patients enrolled
Trial Details
Trial ID
NCT02198300
Start Date
November 1 2012
End Date
March 1 2015
Last Update
July 30 2015
Active Locations (1)
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1
Central Clinical Hospital of the Ministry of Interior
Warsaw, Masovian Voivodeship, Poland, 02-507