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

Brief summary (registry, in English)

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.

What you commit to

• Study type: Interventional · Phase 4
• Participants enrolled: 3113
• From 22 Oct 2019 to the primary completion date, 1 Jan 2025
• 1 site in 1 country
• Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Who the study is looking for

Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

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