Ischaemic Heart Disease Clinical Trial
Official title:
Randomized Comparison of a Polymer-Free Biolimus-eluting BIOFREEDOM Stent With a Biodegradable-Polymer Sirolimus-eluting ORSIRO Stent in Patients Treated With Percutaneous Coronary Intervention
The aim of the Danish Organization for Randomized Trials with Clinical Outcome (SORT OUT) is to compare the safety and efficacy of the polymer-free Biolimus-eluting BIOFREEDOM stent with a biodegradable-polymer Sirolimus-eluting ORSIRO stent in a population-based setting, using registry detection of clinically driven events
SORT OUT IX is a randomized, multicenter, all-comer, two-arm, non-inferiority trial comparing
the polymer-free Biolimus-eluting BIOFREEDOM stent with a biodegradable-polymer
Sirolimus-eluting ORSIRO stent in treating atherosclerotic coronary artery lesions.
Patients will be enrolled by the investigators and randomly allocated to treatment groups
after diagnostic coronary angiography and before percutaneous coronary intervention. Block
randomization by centre (permuted blocks of random sizes (2/4/6)) will be used to assign
patients in a 1:1 ratio to receive the polymer-free Biolimus-eluting BIOFREEDOM stent
(Biosensors) or the biodegradable-polymer Sirolimus-eluting ORSIRO stent (Biotronik). A web
based Trial Partner randomization system will be used.
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