NCT03508219 - POLish Bifurcation Optimal Treatment Strategy Study for Left Main Bifurcation Percutaneous Coronary Intervention (PCI) | Biotech Hunter

Enrollment

130

Participants

Timeline

Start Date

August 10, 2018

Primary Completion Date

April 15, 2021

Study Completion Date

April 15, 2021

Conditions

Coronary Stenosis

Interventions

DEVICE

BiOSS LIM C

"The BiOSS LIM C (Bifurcation Optimization Stent System, Balton, Warsaw, Poland). The BiOSS LIM C is a dedicated bifurcation stent covered with a mixture of a biodegradable polymer and the antiproliferative substance sirolimus. BiOSS LIM C will be used for treatment of the Left-Main bifurcation, according to its instructions for use.~The Alex-Plus cobaltchromium sirolimus eluting stent (Balton, Warsaw, Poland) will be used for treatment of distal left-main side branches according to its instructions for use (i.e. proximal segments of the left anterior descending and left circumflex arteries as well as the ramus intermedius if the latter vessel is part of a trifurcation).~All other lesions (other than left-main bifurcations) will be treated with XIENCE family everolimus-eluting coronary stent systems."

Trial Locations (15)

Unknown

Research Centre FRA-001, Aix-en-Provence

Research Centre FRA-004, Bron

Research Centre FRA-003, Grenoble

Research Centre FRA-002, Saint-Denis

Research Centre ITA-001, Naples

Research Centre ITA-002, Ragusa

Research Centre ITA-003, Syracuse

Research Centre PL-006, Katowice

Research Centre PL-007, Krakow

Research Centre PL-004, Olsztyn

Research Centre PL-005, Poznan

Research Centre PL-001, Warsaw

Research Centre PL-008, Warsaw

Research Centre PL-002, Zabrze

Research Centre PL-003, Zabrze