Clinical trial NCT06475625: Clinical Impact of Orsiro™ Stent in Patient With Chronic Kidney Disease
Official title: Clinical Impact of Orsiro™ Stent in Patient With Chronic Kidney Disease Undergoing Percutaneous Coronay Intervention : A Multicenter, Prospective All-comers Registry
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Chronic Kidney Diseases
Coronary Artery Disease
Keywords: Chronic Kidney Diseases
Coronary Artery Disease
Orsiro stent
Lead sponsor: The Catholic University of Korea
Sponsor class: OTHER
First posted: 2024-06-26
Enrollment: 3113
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 19 years of age or older
* Patient undergoing percutaneous coronary intervention with Orsiro™ or Orsiro_Mission™ stents

Exclusion Criteria:

* 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

Primary outcomes:
measure: Target-lesion failure (TLF)
timeFrame: Within one year after the intervention
Secondary outcomes:
measure: Number of participants with all cause death
timeFrame: Within three years after the intervention
measure: Number of participants with cardiac death
timeFrame: Within three years after the intervention
measure: Number of participants with myocardial infarction
timeFrame: Within three years after the intervention
measure: Number of participants with composite of death or myocardial infarction
timeFrame: Within three years after the intervention
measure: Number of participants with composite of cardiac death or myocardial infarction
timeFrame: Within three years after the intervention
measure: Number of participants with target-vessel revascularization
timeFrame: Within three years after the intervention
measure: Number of participants with target-lesion revascularization
timeFrame: Within three years after the intervention
measure: Number of participants with stent thrombosis
timeFrame: Within three years after the intervention
measure: Number of participants with target-vessel failure
timeFrame: Within three years after the intervention
Other outcomes:
Locations:
city: Daejeon
country: Korea, Republic of
facility: Daejeon St. Mary's Hospital , The Catholic University of Korea
Study officials:
affiliation: Daejeon St. Mary's Hospital , The Catholic University of Korea
name: Mahn-Won Park
role: STUDY_CHAIR
References: