Clinical Impact of Orsiro™ Stent in Patient With Chronic Kidney Disease
- Conditions
- Chronic Kidney DiseasesCoronary Artery Disease
- Interventions
- Procedure: Percutaneous coronary interventionDevice: Orsiro™ or Orsiro_Mission™ stent
- Registration Number
- NCT06475625
- Lead Sponsor
- The Catholic University of Korea
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 3113
- 19 years of age or older
- Patient undergoing percutaneous coronary intervention with Orsiro™ or Orsiro_Mission™ stents
- Patient with a life expectancy of less than one year
- Patient who used another drug-eluting stent for percutaneous coronary intervention at study registration time
- Cardiogenic shock
- Pregnancy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Normal or mild renal dysfunction Percutaneous coronary intervention eGFR ≥ 60 ml·min - 1·1.73㎡ Normal or mild renal dysfunction Orsiro™ or Orsiro_Mission™ stent eGFR ≥ 60 ml·min - 1·1.73㎡ Moderate renal dysfunction Orsiro™ or Orsiro_Mission™ stent 30≤ eGFR\< 60 ml·min - 1·1.73㎡ Severe renal dysfunction Percutaneous coronary intervention eGFR \< 30 ml·min -1·1.73㎡ Moderate renal dysfunction Percutaneous coronary intervention 30≤ eGFR\< 60 ml·min - 1·1.73㎡ Severe renal dysfunction Orsiro™ or Orsiro_Mission™ stent eGFR \< 30 ml·min -1·1.73㎡
- Primary Outcome Measures
Name Time Method Target-lesion failure (TLF) 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
- Secondary Outcome Measures
Name Time Method Number of participants with myocardial infarction Within three years after the intervention periprocedural or spontaneous
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 cardiac death Within three years after the intervention Number of participants with target-vessel revascularization Within three years after the intervention Number of participants with target-vessel failure Within three years after the intervention composite of composite of death, nonfatal myocardial infarction and ischemia-drive target-vessel revascularization (TVR)
Number of participants with all cause death 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 Within three years after the intervention Stent thrombosis appropriate for Academic Research Consortium criteria
Trial Locations
- Locations (1)
Daejeon St. Mary's Hospital , The Catholic University of Korea
🇰🇷Daejeon, Korea, Republic of