Clinical Impact of Orsiro™ Stent in Patient With Chronic Kidney Disease (OKAY)

The Catholic University of Korea

Status and phase: Active, not recruiting; Phase 4

Conditions: Coronary Artery Disease; Chronic Kidney Diseases

Treatments: Device: Orsiro™ or Orsiro_Mission™ stent; Procedure: Percutaneous coronary intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT06475625

DC190OEDI0069

Details and patient eligibility

About

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.

Enrollment: 3,113 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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3,113 participants in 3 patient groups

Normal or mild renal dysfunction

Experimental group

Description:

eGFR ≥ 60 ml·min - 1·1.73㎡

Treatment:

Procedure: Percutaneous coronary intervention

Device: Orsiro™ or Orsiro_Mission™ stent

Moderate renal dysfunction

Experimental group

Description:

30≤ eGFR\< 60 ml·min - 1·1.73㎡

Treatment:

Procedure: Percutaneous coronary intervention

Device: Orsiro™ or Orsiro_Mission™ stent

Severe renal dysfunction

Experimental group

Description:

eGFR \< 30 ml·min -1·1.73㎡

Treatment:

Procedure: Percutaneous coronary intervention

Device: Orsiro™ or Orsiro_Mission™ stent