Daejeon St. Mary's Hospital , The Catholic University of Korea
Daejeon, South Korea
NCT Number: NCT06475625
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.
This study is active but is not currently recruiting participants.
19 year and older
All sexes
Interventional
Phase 4
Daejeon, South Korea
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Percutaneous coronary intervention
Percutaneous coronary intervention with Orsiro™ or Orsiro_Mission™ stents
Time frame: Within one year after the intervention
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
Time frame: Within three years after the intervention
Time frame: Within three years after the intervention
Time frame: Within three years after the intervention
periprocedural or spontaneous
Time frame: Within three years after the intervention
Time frame: Within three years after the intervention
Time frame: Within three years after the intervention
Time frame: Within three years after the intervention
Time frame: Within three years after the intervention
Stent thrombosis appropriate for Academic Research Consortium criteria
Time frame: Within three years after the intervention
composite of composite of death, nonfatal myocardial infarction and ischemia-drive target-vessel revascularization (TVR)
The Catholic University of Korea
Other
Clinical Impact of Orsiro™ Stent in Patient With Chronic Kidney Disease Undergoing Percutaneous Coronay Intervention : A Multicenter, Prospective All-comers Registry
Acronym: OKAY
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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