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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04825886
Other study ID # CNUH-2017-319
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 28, 2017
Est. completion date March 18, 2022

Study information

Verified date February 2024
Source Chonnam National University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

This study is to evaluation the efficacy and safety of Zotarolimus-Eluting Stent in patients with long coronary artery disease of 25 mm or longer.


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.


Recruitment information / eligibility

Status Completed
Enrollment 2000
Est. completion date March 18, 2022
Est. primary completion date March 18, 2021
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility 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 Design


Intervention

Device:
Zotarolimus-Eluting Stent
Percutaneous coronary intervention using zotarolimus-eluting stent

Locations

Country Name City State
Korea, Republic of Gyeongsang National University Changwon Hospital Changwon
Korea, Republic of Dankook University Hospital Cheonan
Korea, Republic of Konkuk University Medical Center Chungju
Korea, Republic of Daegu Catholic University Hospital Daegu
Korea, Republic of Keimyung University Dongsan Medical Center Daegu
Korea, Republic of Kyungpook National University Hospital Daegu
Korea, Republic of Yeungnam University Medical Center Daegu
Korea, Republic of Eulji Medical Center Daejeon
Korea, Republic of Kongyang Univeristy Hospital Daejeon
Korea, Republic of Chonnam National University Hospital Gwangju
Korea, Republic of Chosun University Hospital Gwangju
Korea, Republic of Wongkwang University Hospital Iksan
Korea, Republic of Jeonbuk National University Hospital Jeonju
Korea, Republic of Presbyterian Medical Center Jeonju
Korea, Republic of Dong-A University Hospital Pusan
Korea, Republic of Kosin University Gospel Hospital Pusan
Korea, Republic of Paik Hospital Pusan
Korea, Republic of Pusan National University Hospital Pusan
Korea, Republic of Saint Carollo Hospital Suncheon
Korea, Republic of Pusan National University Yangsan Hospital Yangsan

Sponsors (1)

Lead Sponsor Collaborator
Chonnam National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Target lesion failure Composite endpoint of clinically driven target lesion revascularization, myocardial infarction or cardiac death related to target vessel Index admission to 12 months
Secondary All-cause death Cumulative incidence rate of all-cause death at each visit Index admission, 1 month, 6 months, 12 months
Secondary Cardiac death Cumulative incidence rate of cardiac death at each visit Index admission, 1 month, 6 months, 12 months
Secondary Myocardial Infarction Cumulative incidence rate of myocardial infarction at each visit Index admission, 1 month, 6 months, 12 months
Secondary All-cause death or Myocardial infarction Cumulative incidence rate of all-cause death or myocardial infarction at each visit Index admission, 1 month, 6 months, 12 months
Secondary Cardiac death or Myocardial infarction umulative incidence rate of cardiac death or myocardial infarction at each visit Index admission, 1 month, 6 months, 12 months
Secondary Target vessel revascularization Cumulative incidence rate of target vessel revascularization at each visit Index admission, 1 month, 6 months, 12 months
Secondary Target lesion revascularization Cumulative incidence rate of target lesion revascularization at each visit Index admission, 1 month, 6 months, 12 months
Secondary Stent thrombosis Cumulative incidence rate of stent thrombosis at each visit Index admission, 1 month, 6 months, 12 months
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