Ignite Creation Date:
2024-07-17 @ 11:01 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06475625
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-26
First Post:
2024-06-18
Brief Title:
Clinical Impact of Orsiro Stent in Patient With Chronic Kidney Disease
Sponsor:
The Catholic University of Korea
Organization:
The Catholic University of Korea
Study Overview
Official Title:
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
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OKAY
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 mlmin - 1173 moderate renal dysfunction 30 eGFR 60 mlmin - 1173 and severe renal dysfunction eGFR 30 mlmin -1173 the clinical outcome will be investigated among groups
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None