Coronary Heart Disease Clinical Trial
Official title:
Intracoronary Stenting and Angiographic Results: ORSIRO Stents Versus Xience PRIME Stents Assessed by Optical Coherence Tomography
This prospective, randomized trial will compare the extent of covered stent strut segments by assessed by Optical Coherence Tomography (OCT) of the ORSIRO DES with that of the XIENCE PRIME DES, which is the standard of choice of contemporary drug eluting stents (DES).
The ORSIRO drug eluting stent exhibits a favourable vascular healing profile from baseline to 6 months assessed by optical coherence tomography (OCT). Patients with symptomatic coronary artery disease without cardiogenic shock who will undergo coronary angiography and willing to participate in the trial will receive before the procedure a loading dose of P2Y12 antagonists (clopidogrel, prasugrel or ticagrelor). Eligible patients who do not meet the exclusion criteria and for whom PCI will be considered as the appropriate form of revascularization will be randomly assigned to the ORSIRO or the XIENCE PRIME DES in the relation 1 x ORSIRO: 1 x XIENCE PRIME. All patients will receive periprocedural intravenous aspirin and heparin or bivalirudin. After the intervention patients will receive aspirin indefinitely and P2Y12 antagonists for at least 6 months. The intravascular imaging by OCT will be performed at the 6-8 months follow-up angiography. ;
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