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  • Status : Approved
    • First Submitted Date : 2021/02/09
    • Registered Date : 2021/04/07
    • Last Updated Date : 2021/02/09
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1. Background

Background Information
CRIS
Registration Number
KCT0006069 
Unique Protocol ID CUI2018-0054 
Public/Brief Title CAlcified Plaque In patients receiving Resolute Onyx® 
Scientific Title CAlcified Plaque In patients receiving Resolute Onyx®  
Acronym CAPIRO 
MFDS Regulated Study No
IND/IDE Protocol
Registered
at Other Registry
No
Healthcare Benefit
Approval Status
Not applicable

2. Institutional Review Board/Ethics Committee

Institutional Review Board Information
Board Approval Status Submitted approval 
Board Approval Number 2018-03-050 
Approval Date 2018-05-25 
Institutional Review Board  
Name Jeonbuk National University Hospital Institutional Review Board 
Address 20, Geonji-ro, Deokjin-gu, Jeonju-si, Jeollabuk-do 
Telephone 063-250-2154 
Data Monitoring Committee  

3. Contact Details

Contact Details Information
Contact Person for Principal Investigator / Scientific Queries  
Name Sangrok Lee 
Title Professor 
Telephone +82-63-250-2418 
Affiliation Jeonbuk National University Hospital 
Address 20, Geonji-ro, Deokjin-gu, Jeonju-si, Jeollabuk-do 
Contact Person for Public Queries
Name Jawon Lee 
Title CRC 
Telephone +82-7597-3267 
Affiliation Jeonbuk National University Hospital 
Address 20, Geonji-ro, Deokjin-gu, Jeonju-si, Jeollabuk-do 
Contact Person for Updating Information
Name Jawon Lee 
Title CRC 
Telephone +82-7597-3267 
Affiliation Jeonbuk National University Hospital 
Address 20, Geonji-ro, Deokjin-gu, Jeonju-si, Jeollabuk-do 

4. Status

Status Information
Study Site Multi-center (Number of center : 3)
Overall Recruitment Status Recruiting  
Date of First Enrollment 2018-07-31 , Actual
Target Number of Participant 300
Primary Completion Date
Study Completion Date 2024-06-30 , Anticipated
Recruitment Status by Participating Study Site 1
Name of Study Site Jeonbuk National University Hospital 
Recruitment Status Recruiting  
Date of First Enrollment 2018-07-31 , Actual
Recruitment Status by Participating Study Site 2
Name of Study Site Wonkwang University Hospital 
Recruitment Status Recruiting  
Date of First Enrollment 2018-09-18 , Actual
Recruitment Status by Participating Study Site 3
Name of Study Site Presbyterian Medical Center 
Recruitment Status Recruiting  
Date of First Enrollment 2018-11-12 , Actual

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information
Source of Monetary/Material Support 1   
Organization Name Medtronic Korea 
Organization Type Others  
Project ID  

6. Sponsor Organization

Sponsor Organization Information
Sponsor Organization 1   
Organization Name Jeonbuk National University Hospital 
Organization Type Medical Institute  

7. Study Summary

Study Summary Information
Lay Summary [Background]
Resolute Onyx DES was proposed to be built on the Integrity platform for even greater flexibility and conformability. Featured Core wire technology, having a denser core metal wrapped in a cobalt alloy outer layer, enhances deliverability in challenging coronary anatomies, and improves conformability against the vessel wall and increases radiopacity, i.e. visibility during coronary intervention with no compromise to radial and longitudinal strength, despite being composed of thinner stent struts as compared with Resolute Integrity ZES (81 μm vs. 91 μm, respectively). Recent result showed Resolute Onyx have a lower crossing profile and improved trackability about 20% more than RI-ZES. Furthermore, Resolute Onyx DES with increased strut width to thickness ratio showed higher radial strength compared to RI-DES. Regarding these features, Resolute Onyx DES will be anticipated in improved clinical outcomes regard to better vessel conformability especially in complex lesions such as long, calcified and tortuous lesions.

However, there is a paucity of data on clinical outcome in patients with CAC receiving zotarolimus-eluting stents. The present study would be prospective, multicenter, post-approval study to examine the 12-month and 24-month effectiveness of Resolute Onyx® stents in all comer CAD patients who have CAC.

[Study hypothesis]
The 12- and 24-month effectiveness of Resolute Onyx® stents in patients with angiographically moderate or severe coronary artery calcification (group I) would be comparable with mild or no calcification lesions (group II). Resolute Onyx® stents will show similar procedure success rate even in moderate or severe calcification patients.

[Study design]
Prospective, multicenter, post-approval study designed to examine the 12-month and 24-month effectiveness of Resolute Onyx® stents in moderate or severe CAC.  

8. Study Design

Study Design Information
Study Type Observational Study 
Observational Study Model Cohort 
Time Perspective Prospective    
Target Number of Participant 300
Cohort/Group Number
Cohort/
Group 1
Cohort/Group
Label
Group I (Moderate Calcification, n=100) 
Cohort/Group
Description
Categorized as three groups according to the degree of calcification in coronary angiography. Moderate (Score 2, Group I): CAC is easily observed(if there is only radiation shade observed during cardiac movement before contrast medium is administered) 
Biospecimen
Collection & Archiving
Not collect nor Archive 
Biospecimen Description  
Cohort/
Group 2
Cohort/Group
Label
Group II (Severe Calcification, n=100) 
Cohort/Group
Description
Categorized as three groups according to the degree of calcification in coronary angiography. Severe (High, Score 3, Group II): severe CAC (when prominent shading invading both sides of the coronary artery is observed regardless of heart movement prior to the administration of the contrast medium) 
Biospecimen
Collection & Archiving
Not collect nor Archive 
Biospecimen Description  
Cohort/
Group 3
Cohort/Group
Label
Group III (No or Mild Calcification, n=100) 
Cohort/Group
Description
Categorized as three groups according to the degree of calcification in coronary angiography. Zero (Score 0, Group III): No CAC mild (Score 1, Group III): CAC observed only after close observation (radio-shading observed in part of the heart cycle) 
Biospecimen
Collection & Archiving
Not collect nor Archive 
Biospecimen Description  

9. Subject Eligibility

Subject Eligibility Information
Study Population Description Patients who have CAD and amendable for implantation of Resolute Onyx® stents during the index PCI would be enrolled.  
Sampling Method Patients who visited the hospital during the period and inserted Resolute Onyx stent due to coronary disease.  
Condition(s)/Problem(s) * Diseases of the circulatory system
Rare Disease No
Inclusion
Criteria
Gender Both 
Age 19 Year ~ No Limit
Description The patient must be ≥18 years of age. <br /> <br />The patient has CAD and needs to be treated with stenting. CAD includes stable angina pectoris and acute coronary syndrome (unstable angina pectoris, non-ST-elevation myocardial infarction (MI), or ST-elevation MI). Patients with chronic total occlusion are also deemed eligible. <br /> <br />The patient has consented to participate and has authorized the collection and release of his medical information by signing the “Patient Informed Consent Form” <br /> <br />The patient or guardian is willing and able to cooperate with study procedures and required follow up visits.  
Exclusion Criteria Patients with left main disease <br /> <br />Patients with cardiogenic shock <br /> <br />Patients who have contraindication for 12-month dual anti-platelet therapy (DAPT). <br /> <br />Female of childbearing potential, who possibly plans to become pregnant any time after enrollment into this study. <br /> <br />Patients with hypersensitivity or allergies to the drug or components indicated in the Instructions for Use of the stent. <br /> <br />History of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia), or will refuse blood transfusions. <br /> <br />Gastrointestinal or genitourinary bleeding within the prior 3 months, or major surgery within 2 months. <br /> <br />Current known platelet count &lt;50,000 cells/mm3 or Hgb &lt;8 g/dL. <br /> <br />Patients with cardiogenic shock <br /> <br />Patients with a life expectancy shorter than 12 months  
Healthy Volunteers No

10. Outcome Measure(s)

Outcome Measure(s) Information
Type of Primary Outcome Efficacy 
Primary Outcome(s) 1 
Outcome MACE(Major adverse cardiac events) is defined as the composite of cardiac death, new MI, ischemia-driven target vessel revascularization (TVR) by either PCI or CABG. 
Timepoint 12Month 
Secondary Outcome(s) 1 
Outcome Major adverse cardiac events 
Timepoint 24 months 
Secondary Outcome(s) 2 
Outcome Composite of all cause death, new myocardial infarction, stent thrombosis, ischemia-driven target vessel revascularization 
Timepoint 12 months and 24 months 
Secondary Outcome(s) 3 
Outcome Acute procedure success rate during the index PCI 
Timepoint N/A 
Secondary Outcome(s) 4 
Outcome MACE according to calcium index of IVUS 
Timepoint 12 months and 24 months 

11. Study Results and Publication

Study Results and Publication Information
Result Registered No

12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

Sharing of Study Data Information
Sharing Statement No 
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