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OpenTrials
Active, Not Recruiting

NCT Number: NCT06475625

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Percutaneous coronary intervention

Procedure

Percutaneous coronary intervention

Orsiro™ or Orsiro_Mission™ stent

Device

Percutaneous coronary intervention with Orsiro™ or Orsiro_Mission™ stents

Primary outcomes

  1. Target-lesion failure (TLF)

    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

Secondary outcomes

  1. Number of participants with all cause death

    Time frame: Within three years after the intervention

  2. Number of participants with cardiac death

    Time frame: Within three years after the intervention

  3. Number of participants with myocardial infarction

    Time frame: Within three years after the intervention

    periprocedural or spontaneous

  4. Number of participants with composite of death or myocardial infarction

    Time frame: Within three years after the intervention

  5. Number of participants with composite of cardiac death or myocardial infarction

    Time frame: Within three years after the intervention

  6. Number of participants with target-vessel revascularization

    Time frame: Within three years after the intervention

  7. Number of participants with target-lesion revascularization

    Time frame: Within three years after the intervention

  8. Number of participants with stent thrombosis

    Time frame: Within three years after the intervention

    Stent thrombosis appropriate for Academic Research Consortium criteria

  9. Number of participants with target-vessel failure

    Time frame: Within three years after the intervention

    composite of composite of death, nonfatal myocardial infarction and ischemia-drive target-vessel revascularization (TVR)

Sponsors and collaborators

Lead sponsor

The Catholic University of Korea

Other

Registry information

Official study title

Clinical Impact of Orsiro™ Stent in Patient With Chronic Kidney Disease Undergoing Percutaneous Coronay Intervention : A Multicenter, Prospective All-comers Registry

Acronym: OKAY

Important dates

Study start
2019
Primary completion
2025
Study completion
2027
First posted
Jun 26, 2024
Registry last updated
Jun 26, 2024

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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