NCT06475625

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

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

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 3,113 (actual)
• Sponsor: The Catholic University of Korea · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
PROCEDURE	Percutaneous coronary intervention	Percutaneous coronary intervention
DEVICE	Orsiro™ or Orsiro_Mission™ stent	Percutaneous coronary intervention with Orsiro™ or Orsiro\_Mission™ stents

Timeline

• Start date: 2019-10-22
• Primary completion: 2025-01-01
• Completion: 2027-01-01
• First posted: 2024-06-26
• Last updated: 2024-06-26

Locations

1 site across 1 country: South Korea