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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

3113 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-22

Study Completion Date

2027-01-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Chronic Kidney Diseases Coronary Artery Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Normal or mild renal dysfunction

eGFR ≥ 60 ml·min - 1·1.73㎡

Group Type EXPERIMENTAL

Percutaneous coronary intervention

Intervention Type PROCEDURE

Percutaneous coronary intervention

Orsiro™ or Orsiro_Mission™ stent

Intervention Type DEVICE

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

Moderate renal dysfunction

30≤ eGFR\< 60 ml·min - 1·1.73㎡

Group Type EXPERIMENTAL

Percutaneous coronary intervention

Intervention Type PROCEDURE

Percutaneous coronary intervention

Orsiro™ or Orsiro_Mission™ stent

Intervention Type DEVICE

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

Severe renal dysfunction

eGFR \< 30 ml·min -1·1.73㎡

Group Type EXPERIMENTAL

Percutaneous coronary intervention

Intervention Type PROCEDURE

Percutaneous coronary intervention

Orsiro™ or Orsiro_Mission™ stent

Intervention Type DEVICE

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

Interventions

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Percutaneous coronary intervention

Intervention Type PROCEDURE

Orsiro™ or Orsiro_Mission™ stent

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 19 years of age or older
* Patient undergoing percutaneous coronary intervention with Orsiro™ or Orsiro\_Mission™ stents

Exclusion Criteria

* Patient with a life expectancy of less than one year
* Patient who used another drug-eluting stent for percutaneous coronary intervention at study registration time
* Cardiogenic shock
* Pregnancy

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No