- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04825886
Efficacy and Safety of ZotaRolimus-Eluting Coronary Stent System In Patients With Long Coronary Artery Disease
Evaluation of Effectiveness and Safety of ZotaRolimus-Eluting Coronary Stent System In Patients With Long Coronary Artery Disease; A Multicenter, Prospective, Observational Registry Study
Study Overview
Status
Intervention / Treatment
Detailed Description
Study objectives:
From this observational prospective study, the efficacy and safety of Zotarolimus-Eluting Stent in patients with coronary artery disease longer than 25mm is planned to be investigated.
Background:
Long coronary artery lesions are observed in 20% of all coronary interventions, and are associated with poor clinical outcomes. Zotarolimus-Eluting Stents are a new type of stent that combines the advantages of an Endeavour Resolute stent (drug eluting stent) and Integrity stent (bare metal stent). In other words, BioLinx polymer is used which is an advantage of Endeavour Resolute stent to secure clinical efficiency through stable drug release while ensuring flexibility and excellent deliverability, which is the advantage of Integrity stent. To date, there are only few studies to evaluate the efficacy and safety of Zotarolimus-Eluting Stent in the treatment of coronary artery disease. Therefore, the investigators planned to carry out a multicenter, prospective observational study to evaluated the efficacy and safety of Zotarolimus-Eluting Stent in patients with long coronary artery disease of 25 mm or longer.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Changwon, Korea, Republic of
- Gyeongsang National University Changwon Hospital
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Cheonan, Korea, Republic of
- Dankook University Hospital
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Chungju, Korea, Republic of
- Konkuk University Medical Center
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Daegu, Korea, Republic of
- Keimyung University Dongsan Medical Center
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Daegu, Korea, Republic of
- Kyungpook National University Hospital
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Daegu, Korea, Republic of
- Yeungnam University Medical Center
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Daegu, Korea, Republic of
- Daegu Catholic University Hospital
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Daejeon, Korea, Republic of
- Eulji Medical Center
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Daejeon, Korea, Republic of
- Kongyang Univeristy Hospital
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Gwangju, Korea, Republic of
- Chonnam National University Hospital
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Gwangju, Korea, Republic of
- Chosun university hospital
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Iksan, Korea, Republic of
- Wongkwang University Hospital
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Jeonju, Korea, Republic of
- Presbyterian Medical Center
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Jeonju, Korea, Republic of
- Jeonbuk National University Hospital
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Pusan, Korea, Republic of
- Pusan National University Hospital
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Pusan, Korea, Republic of
- Dong-A University Hospital
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Pusan, Korea, Republic of
- Kosin University Gospel Hospital
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Pusan, Korea, Republic of
- Paik Hospital
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Suncheon, Korea, Republic of
- Saint Carollo Hospital
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Yangsan, Korea, Republic of
- Pusan National University Yangsan Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age ≥ 19 years old
- Evidence of myocardial ischemia and coronary artery diameter stenosis≥ 50% and lesion length ≥ 25mm
- At least 2.5 mm diameter coronary vessel by visual estimation
- Patients treated with Zotarolimus-eluting stent
Exclusion Criteria:
- Previous coronary stent implantation
- Patients perticipated in other clinical trials of drugs or device
- Target vessel saphenous vein graft
- In-stent re-stenosis lesion
- Contraindicated to anti-platelet agents or hypersensitivity
- Past history of malignancy within 5 years
- History of anaphylaxis to contrast agent
- Pregnancy and lactation
- Life expectancy < 1-year
- End stage renal disease on dialysis
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Target lesion failure
Time Frame: Index admission to 12 months
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Composite endpoint of clinically driven target lesion revascularization, myocardial infarction or cardiac death related to target vessel
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Index admission to 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
All-cause death
Time Frame: Index admission, 1 month, 6 months, 12 months
|
Cumulative incidence rate of all-cause death at each visit
|
Index admission, 1 month, 6 months, 12 months
|
Cardiac death
Time Frame: Index admission, 1 month, 6 months, 12 months
|
Cumulative incidence rate of cardiac death at each visit
|
Index admission, 1 month, 6 months, 12 months
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Myocardial Infarction
Time Frame: Index admission, 1 month, 6 months, 12 months
|
Cumulative incidence rate of myocardial infarction at each visit
|
Index admission, 1 month, 6 months, 12 months
|
All-cause death or Myocardial infarction
Time Frame: Index admission, 1 month, 6 months, 12 months
|
Cumulative incidence rate of all-cause death or myocardial infarction at each visit
|
Index admission, 1 month, 6 months, 12 months
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Cardiac death or Myocardial infarction
Time Frame: Index admission, 1 month, 6 months, 12 months
|
umulative incidence rate of cardiac death or myocardial infarction at each visit
|
Index admission, 1 month, 6 months, 12 months
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Target vessel revascularization
Time Frame: Index admission, 1 month, 6 months, 12 months
|
Cumulative incidence rate of target vessel revascularization at each visit
|
Index admission, 1 month, 6 months, 12 months
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Target lesion revascularization
Time Frame: Index admission, 1 month, 6 months, 12 months
|
Cumulative incidence rate of target lesion revascularization at each visit
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Index admission, 1 month, 6 months, 12 months
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Stent thrombosis
Time Frame: Index admission, 1 month, 6 months, 12 months
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Cumulative incidence rate of stent thrombosis at each visit
|
Index admission, 1 month, 6 months, 12 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Youngkeun Ahn, MD, Chonnam National University Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CNUH-2017-319
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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