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

NCT06475625 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 3113

Last updated 2024-06-26

No results posted yet for this study

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

Interventions

PROCEDURE

Percutaneous coronary intervention

Percutaneous coronary intervention

DEVICE

Orsiro™ or Orsiro_Mission™ stent

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

Sponsors & Collaborators

  • The Catholic University of Korea

    lead OTHER

Principal Investigators

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

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-22
Primary Completion
2025-01-01
Completion
2027-01-01

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06475625 on ClinicalTrials.gov