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

NCT06475625 | Active Not Recruiting Phase 4 DMC

• 1 other identifier: DC190OEDI0069
• Study Type: interventional
• Target: 3,113
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Diseases; Coronary Artery Disease

Keywords

Chronic Kidney Diseases; Coronary Artery Disease; Orsiro stent

Outcome Measures

Primary Outcomes (1)

• Target-lesion failure (TLF)

  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 Outcomes (9)

• Number of participants with all cause death

  Within three years after the intervention

• Number of participants with cardiac death

  Within three years after the intervention

• Number of participants with myocardial infarction

  Within three years after the intervention

• 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

Study Arms (3)

Normal or mild renal dysfunction

EXPERIMENTAL

eGFR ≥ 60 ml·min - 1·1.73㎡

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

Moderate renal dysfunction

EXPERIMENTAL

30≤ eGFR\< 60 ml·min - 1·1.73㎡

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

Severe renal dysfunction

EXPERIMENTAL

eGFR \< 30 ml·min -1·1.73㎡

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

Interventions

Percutaneous coronary intervention PROCEDURE

Percutaneous coronary intervention

Moderate renal dysfunction; Normal or mild renal dysfunction; Severe renal dysfunction

Orsiro™ or Orsiro_Mission™ stent DEVICE

Percutaneous coronary intervention with Orsiro™ or Orsiro\_Mission™ stents

Moderate renal dysfunction; Normal or mild renal dysfunction; Severe renal dysfunction

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older
• Patient undergoing percutaneous coronary intervention with Orsiro™ or Orsiro\_Mission™ stents

You may not qualify if:

• 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

Sponsors & Collaborators

• The Catholic University of Korea: lead

Study Sites (1)

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

Daejeon, South Korea

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Coronary Artery Disease

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Mahn-Won Park

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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 18, 2024
• First Posted: June 26, 2024
• Study Start: October 22, 2019
• Primary Completion: January 1, 2025
• Study Completion (Estimated): January 1, 2027
• Last Updated: June 26, 2024

Record last verified: 2024-06

Locations

KR (1)