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ACTIVE NOT RECRUITING
NCT06475625
PHASE4

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

Sponsor: The Catholic University of Korea

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

19 Years - Any

Study Type

INTERVENTIONAL

Enrollment

3113

Start Date

2019-10-22

Completion Date

2027-01-01

Last Updated

2024-06-26

Healthy Volunteers

No

Interventions

PROCEDURE

Percutaneous coronary intervention

Percutaneous coronary intervention

DEVICE

Orsiro™ or Orsiro_Mission™ stent

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

Locations (1)

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

Daejeon, South Korea