Acute Myocardial Infarction Clinical Trial
Official title:
Randomized Comparison of Vascular Healing of a Polymer-Free Biolimus-eluting BIOFREEDOM Stent With a Biodegradable-Polymer Sirolimus-eluting ORSIRO Stent in Patients With ST-segment Elevation Myocardial Infarction
The aim of the Danish Organization for Randomized Trials with Clinical Outcome (SORT OUT) IX STEMI OCT is to compare early vascular healing of the polymer-free Biolimus-eluting BIOFREEDOM stent with a biodegradable-polymer Sirolimus-eluting ORSIRO stent in patients with ST-segment elevation myocardial infarction (STEMI) treated with primary percutaneous coronary intervention (PCI).
SORT OUT IX STEMI OCT is a randomized 1:1 study comparing the polymer-free Biolimus-eluting
BIOFREEDOM stent with a biodegradable-polymer Sirolimus-eluting ORSIRO stent patients with
STEMI treated with primary PCI.
Vascular healing index (uncovered stent struts, malapposed stent struts, maximal intima
coverage and accumulated extra-stent lumen volume) assessed with optical coherence tomography
(OCT) 1 month after primary PCI.
Patients will be enrolled by the investigators and randomly allocated to treatment groups
after diagnostic coronary angiography and before primary PCI. A web based Trial Partner
randomization system will be used.
OCT will be performed with the frequency-domain OPTIS OCT system and Dragonfly™ Imaging
Catheter during the index procedure and after 1 months.
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