The objective of this study is a comparative evaluation of Orsiro stent and of Resolute Integrity stent in terms of the extent of neointima formation at 4 months after implantation using optical coherence tomography (OCT).
About 50 patients with clinical evidence of ischemic heart disease and / or a positive functional study and documented stable angina pectoris (Canadian cardiovascular society classification (CCS)1, 2, 3 or 4), or documented silent ischemia in de-novo, native, previously unstented vessel in Tyumen Cardiology Center,will be randomly assigned undergoing implantation of Orsiro stent or Resolute Integrity stent (in a 1:1 ratio). All of the patients will receive 12 months dual antiplatelet therapy and they will be followed (at the outpatient clinic) for up to 1 year. The follow-up visits will be conducted at 4 months (including angiographic/OCT investigation), and 1 year post percutaneous coronary intervention(PCI),in order to observe the Primary Endpoint and Secondary Endpoints.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
50
Percutaneous coronary intervention with implantation of either: a Orsiro® biolimus a9 eluting coronary stent
Percutaneous coronary intervention with implantation of either: a Resolute Integrity® zotarolimus eluting coronary stent
Tyumen Cardiology Research Center, Tomsk National Research Medical Center, Russian Academy of Science
Tyumen, Russia
Heterogeneous neointimal healing
Endothelial coverage by Heterogeneous neointima of the stent struts assessed by optical coherence tomography
Time frame: 4 ± 1 months
Malapposed stent struts
Percentage of malapposed stent struts by optical coherence tomography
Time frame: 4 ± 1 months
Neointimal growth
Neointimal thickness by optical coherence tomography
Time frame: 4 ± 1 months
Angiographic reference vessel diameter
Reference diameter of coronary artery by QCA
Time frame: 4 ± 1 months
Clinical composite endpoints
Cardiac death/Target vessel MI/Clinically indicated TLR All death/All MI/All TVR (including TLR)
Time frame: 12 months
Stent Thrombosis
Definite stent thrombosis
Time frame: 12 months
Uncovered stent struts
Percentage of uncovered stent struts by optical coherence tomography
Time frame: 4 ± 1 months
Angiographic minimal lumen diameter
Minimal lumen diameter of coronary artery by QCA;
Time frame: 4 ± 1 months
Angiographic diameter stenosis
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Percent diameter stenosis by QCA;
Time frame: 4 ± 1 months
Binary restenosis
Binary restenosis by QCA;
Time frame: 4 ± 1 months
Angiographic late lumen loss
Late lumen loss by QCA;
Time frame: 4 ± 1 months