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

June 24, 2024 updated by: Mahn-Won Park, The Catholic University of Korea

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

3113

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Daejeon, Korea, Republic of
        • Daejeon St. Mary's Hospital , The Catholic University of Korea

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Normal or mild renal dysfunction
eGFR ≥ 60 ml·min - 1·1.73㎡
Procedure: Percutaneous coronary intervention
Percutaneous coronary intervention
Device: Orsiro™ or Orsiro_Mission™ stent
Percutaneous coronary intervention with Orsiro™ or Orsiro_Mission™ stents
Experimental: Moderate renal dysfunction
30≤ eGFR< 60 ml·min - 1·1.73㎡
Procedure: Percutaneous coronary intervention
Percutaneous coronary intervention
Device: Orsiro™ or Orsiro_Mission™ stent
Percutaneous coronary intervention with Orsiro™ or Orsiro_Mission™ stents
Experimental: Severe renal dysfunction
eGFR < 30 ml·min -1·1.73㎡
Procedure: Percutaneous coronary intervention
Percutaneous coronary intervention
Device: Orsiro™ or Orsiro_Mission™ stent
Percutaneous coronary intervention with Orsiro™ or Orsiro_Mission™ stents

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Within one year after the intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with all cause death
Time Frame: Within three years after the intervention
Within three years after the intervention
Number of participants with cardiac death
Time Frame: Within three years after the intervention
Within three years after the intervention
Number of participants with myocardial infarction
Time Frame: Within three years after the intervention
periprocedural or spontaneous
Within three years after the intervention
Number of participants with composite of death or myocardial infarction
Time Frame: Within three years after the intervention
Within three years after the intervention
Number of participants with composite of cardiac death or myocardial infarction
Time Frame: Within three years after the intervention
Within three years after the intervention
Number of participants with target-vessel revascularization
Time Frame: Within three years after the intervention
Within three years after the intervention
Number of participants with target-lesion revascularization
Time Frame: Within three years after the intervention
Within three years after the intervention
Number of participants with stent thrombosis
Time Frame: Within three years after the intervention
Stent thrombosis appropriate for Academic Research Consortium criteria
Within three years after the intervention
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)
Within three years after the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Catholic University of Korea

Investigators

  • Study Chair: Mahn-Won Park, Daejeon St. Mary's Hospital , The Catholic University of Korea

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 22, 2019

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

June 18, 2024

First Submitted That Met QC Criteria

June 24, 2024

First Posted (Actual)

June 26, 2024

Study Record Updates

Last Update Posted (Actual)

June 26, 2024

Last Update Submitted That Met QC Criteria

June 24, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DC190OEDI0069

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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