Clinical Impact of Orsiro™ Stent in Patient With Chronic Kidney Disease
NCT Number: NCT06475625
Acronym: OKAY
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Chronic Kidney Diseases|Coronary Artery Disease
Interventions: PROCEDURE: Percutaneous coronary intervention|DEVICE: Orsiro™ or Orsiro_Mission™ stent
Sponsor: The Catholic University of Korea
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 3113
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2019-10-22
Completion Date: 2027-01-01
Locations: Daejeon St. Mary's Hospital , The Catholic University of Korea, Daejeon, Korea, Republic of

Summary:
Orsiro™ or Orsiro_Mission™ stents have the biodegradable polymer and the thinnest stent strut (60㎛) in commercially available stents, which could minimize chronic inflammation and incomplete endothelialization. In several prior studies, ultrathin strut sirolimus-eluting stent (Orsiro®) showed better outcomes in terms of target lesion failure or target lesion revascularization compared to other contemporary stents. Chronic kidney disease (CKD) is known to be associated with adverse cardiovascular outcome including restenosis or stent thrombosis following percutaneous coronary interventin (PCI), because the patients with CKD have more complex coronary lesion characteristics, severe calcification, and diffuse plaque of the coronary artery. However, there is a paucity of data regarding clinical efficacy of Orsiro® in CKD population. Therefore, this study aims to investigate the differences in clinical outcomes according to renal function in patients undergoing PCI with Orsiro™ or Orsiro_Mission™ stents. After patients will be divided into three groups according to the renal function; normal or mild renal dysfunction (eGFR ≥ 60 ml·min - 1·1.73㎡), moderate renal dysfunction ( 30≤ eGFR\< 60 ml·min - 1·1.73㎡), and severe renal dysfunction (eGFR \< 30 ml·min -1·1.73㎡), the clinical outcome will be investigated among groups.

Primary Outcome Measures: Target-lesion failure (TLF), Number of participants with Target-lesion failure (TLF), defined as composite of cardiac death, target vessel-related myocardial infarction (TVMI) and ischemia-driven target-lesion revascularization (TLR) at 1 year, Within one year after the intervention
Secondary Outcome Measures: Number of participants with all cause death, Within three years after the intervention|Number of participants with cardiac death, Within three years after the intervention|Number of participants with myocardial infarction, periprocedural or spontaneous, Within three years after the intervention|Number of participants with composite of death or myocardial infarction, Within three years after the intervention|Number of participants with composite of cardiac death or myocardial infarction, Within three years after the intervention|Number of participants with target-vessel revascularization, Within three years after the intervention|Number of participants with target-lesion revascularization, Within three years after the intervention|Number of participants with stent thrombosis, Stent thrombosis appropriate for Academic Research Consortium criteria, Within three years after the intervention|Number of participants with target-vessel failure, composite of composite of death, nonfatal myocardial infarction and ischemia-drive target-vessel revascularization (TVR), Within three years after the intervention