임상연구정보서비스

Search: Search

Clinical outcomes of Ultimaster Tansei sirolimus-eluting coronary stent in Complex High-risk Indicated Patients Percutaneous Coronary Intervention

Status Approved

First Submitted Date

2020/11/19
Registered Date

2020/11/27
Last Updated Date

2020/11/19

Move list page

CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

1. Background

Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
CRIS Registration Number	KCT0005639
Unique Protocol ID	2020-06-005
Public/Brief Title	An observational study to evaluate the effectiveness and safety of sirolimus-eluting stents in patients at high risk of cardiovascular disease
Scientific Title	Clinical outcomes of Ultimaster Tansei sirolimus-eluting coronary stent in Complex High-risk Indicated Patients Percutaneous Coronary Intervention
Acronym	U-CHIP
MFDS Regulated Study	No
IND/IDE Protocol	No
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	DSMC 2020-06-005-001
Approval Date	2020-07-10
Institutional Review Board Name	Keimyung University Dongsan Hospital IRB
Institutional Review Board Address	1035, Dalgubeol-daero, Dalseo-gu, Daegu
Institutional Review Board Telephone	053-258-6694
Data Monitoring Committee	No

3. Contact Details

Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
Contact Person for Principal Investigator / Scientific Queries
Name	Seung-Ho Hur
Title	Professor
Telephone	+82-53-258-6663
Affiliation	Keimyung University Dongsan Hospital
Address	1035, Dalgubeol-daero, Dalseo-gu, Daegu, Republic of Korea
Contact Person for Public Queries
Name	Seung-Ho Hur
Title	Professor
Telephone	+82-53-258-6663
Affiliation	Keimyung University Dongsan Hospital
Address	1035, Dalgubeol-daero, Dalseo-gu, Daegu, Republic of Korea
Contact Person for Updating Information
Name	Seung-Ho Hur
Title	Professor
Telephone	+82-53-258-6663
Affiliation	Keimyung University Dongsan Hospital
Address	1035, Dalgubeol-daero, Dalseo-gu, Daegu, Republic of Korea

4. Status

Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
Recruitment Status by Participating Study Site 1
Study Site	Multi-center Number of center : 5
Overall Recruitment Status	Not yet recruiting
Date of First Enrollment	2020-11-25 Anticipated
Target Number of Participant	1500
Primary Completion Date	2022-12-31 , Anticipated
Study Completion Date	2025-12-31 , Anticipated
Name of Study	Keimyung University Dongsan Hospital
Recruitment Status	Not yet recruiting
Date of First Enrollment	2020-11-25 ,
Recruitment Status by Participating Study Site 2
Name of Study	Daegu Catholic University Medical Center
Recruitment Status	Not yet recruiting
Date of First Enrollment	2021-01-04 ,
Recruitment Status by Participating Study Site 3
Name of Study	Kyungpook National University Hospital
Recruitment Status	Not yet recruiting
Date of First Enrollment	2021-01-04 ,
Recruitment Status by Participating Study Site 4
Name of Study	Yeongnam University Medical Center
Recruitment Status	Not yet recruiting
Date of First Enrollment	2021-01-04 ,
Recruitment Status by Participating Study Site 5
Name of Study	Daegu Fatima Hospital
Recruitment Status	Not yet recruiting
Date of First Enrollment	2021-02-01 ,

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
1. Source of Monetary/Material Support
Organization Name	Terumo Corporation
Organization Type	Others
Project ID

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	Keimyung University Dongsan Hospital
Organization Type	Medical Institute

7. Study Summary

Study Summary Information
Lay Summary	The purpose of this study is to analyze the frequency of target lesion failure and predictors, including cardiac death, non-fatal myocardial infarction, and ischemia-based target lesion reoperation after sirolimus elution stent in high-risk patients with coronary artery disease. We want to evaluate the incidence of target lesion treatment failure and device-related events (cardiac death, target-vessel MI, target lesion revascularization, stent thrombosis) for 2 years after stent insertion

Study Summary Information

Lay Summary

The purpose of this study is to analyze the frequency of target lesion failure and predictors, including cardiac death, non-fatal myocardial infarction, and ischemia-based target lesion reoperation after sirolimus elution stent in high-risk patients with coronary artery disease. We want to evaluate the incidence of target lesion treatment failure and device-related events (cardiac death, target-vessel MI, target lesion revascularization, stent thrombosis) for 2 years after stent insertion

8. Study Design

Study Design Information - Study Type, Observational Study Model, Time Perspective, Target Number of Participant, Cohort/Group Number, Cohort/Group, Cohort/Group Label, Cohort/Group Description, Biospecimen Collection & Archiving, Biospecimen Description
Study Type	Observational Study
Observational Study Model	Case-only
Time Perspective	Prospective
Target Number of Participant	1500
Cohort/Group Number	1
Cohort/ Group 1	Cohort/Group Label Patients with high-risk coronary artery disease with sirolimus eluting stent
Cohort/ Group 1	Cohort/Group Description Clinical responses including cardiac death, myocardial infarction, ischemia-based target vascular re-procedure and stent thrombosis after 30 days, 6 months, 1 and 2 years. In addition, laboratory test results, ECG and AE-related data including subsequent coronary angiography, patient suitability for adjuvant antiplatelet therapy 30 days, 1 year, 2 years later, treatment discontinuation, and major bleeding complications.
Biospecimen Collection & Archiving	Not collect nor Archive
Biospecimen Description

9. Subject Eligibility

Subject Eligibility Information
Study Population Description	Patients with high-risk coronary artery disease with sirolimus eluting stent
Sampling Method	Among high-risk patients with coronary artery disease requiring stent insertion, subjects who received sirolimus eluting stent (Ultimaster Tansei).
Condition(s)/Problem(s)	* (I00-I99)Diseases of the circulatory system (I25.1)Atherosclerotic heart disease Coronary Heart Disease
Rare Disease	No
Inclusion Criteria	Gender Both
	Age No Limit~No Limit
	Description * Patients with one of the following conditions among coronary artery disease requiring sirolimus-eluting coronary stent (UltimasterTM TanseiTM) treatment  Complex coronary artery disease -multi-vessel disease-left main disease-severe calcified lesion -chronic total occlusion lesion-bifurcation lesion -diffuse long lesion-small vessel lesion-ostial lesion -thrombus containing lesion-in-stent restenosis lesion -vein graft lesion  Patient comorbidities -advanced age (≥80 years old)-acute coronary syndrome -diabetes-chronic kidney disease (creatinine >1.5 mg/dL) -heart failure (NYHA GIII-IV) -depressed left ventricular function (ejection fraction <50%) -prior cardiac surgery-cardiogenic shock * Patients who have agreed on the study plan and clinical follow-up schedule, and have previously agreed in writing as approved by the research review committee/ethics committee of each clinical research institution
Exclusion Criteria	* When administration of the following drugs is prohibited: aspirin, heparin, clopidogrel, control substance or sirolimus * During the first 6 months post-registration period, pending surgery that requires intervention with antiplatelet drugs is planned. * Women who are lactating, pregnant or wishing to become pregnant * Terminal disease with a lifespan of less than 1 year
Healthy Volunteers	No

10. Outcome Measure(s)

Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
Primary Outcome(s) 1
Type of Primary Outcome	/Safety/Efficacy
Outcome	Target lesion treatment failure
Timepoint	2 years after stent insertion
Secondary Outcome(s) 1
Outcome	Target lesion treatment failure
Timepoint	2 years after stent insertion
Secondary Outcome(s) 2
Outcome	Target vessel treatment failure
Timepoint	2 years after stent insertion
Secondary Outcome(s) 3
Outcome	All Death
Timepoint	2 years after stent insertion
Secondary Outcome(s) 4
Outcome	Cardiac death
Timepoint	2 years after stent insertion
Secondary Outcome(s) 5
Outcome	All Death and Myocardial infarction
Timepoint	2 years after stent insertion
Secondary Outcome(s) 6
Outcome	Cardiac Death and Myocardial infarction
Timepoint	2 years after stent insertion
Secondary Outcome(s) 7
Outcome	Ischemia-driven Target lesion retreatment
Timepoint	2 years after stent insertion
Secondary Outcome(s) 8
Outcome	Ischemia-driven Target vessel retreatment
Timepoint	2 years after stent insertion
Secondary Outcome(s) 9
Outcome	Stent Thrombosis
Timepoint	Up to 2 years after stent treatment
Secondary Outcome(s) 10
Outcome	Bleeding
Timepoint	Up to 2 years after stent treatment

11. Study Results and Publication

Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
Result Registered	No

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

Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
Sharing Statement	No

Move list page Move to top