Efficacy and Safety of ZotaRolimus-Eluting Coronary Stent System In Patients With Long Coronary Artery Disease

Completed

• Conditions: Myocardial Ischemia; Coronary Artery Disease; Coronary Disease

• Registration Number: NCT04825886
• Lead Sponsor: Chonnam National University Hospital

Brief 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.

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 Timeline

• Study Start: 2017-12-28
• Primary Completion: 2021-03-18
• Study First Submitted: 2021-03-27
• Study First Submitted QC: 2021-03-27
• Study First Posted: 2021-04-01
• Study Completion: 2022-03-18
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-05
• Last Update Posted: 2024-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2000

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Target lesion failure	Index admission to 12 months	Composite endpoint of clinically driven target lesion revascularization, myocardial infarction or cardiac death related to target vessel

Secondary Outcome Measures

Name	Time	Method
Target vessel revascularization	Index admission, 1 month, 6 months, 12 months	Cumulative incidence rate of target vessel revascularization at each visit
All-cause death	Index admission, 1 month, 6 months, 12 months	Cumulative incidence rate of all-cause death at each visit
All-cause death or Myocardial infarction	Index admission, 1 month, 6 months, 12 months	Cumulative incidence rate of all-cause death or myocardial infarction at each visit
Stent thrombosis	Index admission, 1 month, 6 months, 12 months	Cumulative incidence rate of stent thrombosis at each visit
Cardiac death	Index admission, 1 month, 6 months, 12 months	Cumulative incidence rate of cardiac death at each visit
Myocardial Infarction	Index admission, 1 month, 6 months, 12 months	Cumulative incidence rate of myocardial infarction at each visit
Target lesion revascularization	Index admission, 1 month, 6 months, 12 months	Cumulative incidence rate of target lesion revascularization at each visit
Cardiac death or Myocardial infarction	Index admission, 1 month, 6 months, 12 months	umulative incidence rate of cardiac death or myocardial infarction at each visit

Trial Locations

Locations (20)

Gyeongsang National University Changwon Hospital; 🇰🇷 Changwon, Korea, Republic of

Konkuk University Medical Center; 🇰🇷 Chungju, Korea, Republic of

Daegu Catholic University Hospital; 🇰🇷 Daegu, Korea, Republic of

Dankook University Hospital; 🇰🇷 Cheonan, Korea, Republic of

Yeungnam University Medical Center; 🇰🇷 Daegu, Korea, Republic of

Kyungpook National University Hospital; 🇰🇷 Daegu, Korea, Republic of

Keimyung University Dongsan Medical Center; 🇰🇷 Daegu, Korea, Republic of

Chonnam National University Hospital; 🇰🇷 Gwangju, Korea, Republic of

Eulji Medical Center; 🇰🇷 Daejeon, Korea, Republic of

Kongyang Univeristy Hospital; 🇰🇷 Daejeon, Korea, Republic of

Jeonbuk National University Hospital; 🇰🇷 Jeonju, Korea, Republic of

Presbyterian Medical Center; 🇰🇷 Jeonju, Korea, Republic of

Chosun University Hospital; 🇰🇷 Gwangju, Korea, Republic of

Wongkwang University Hospital; 🇰🇷 Iksan, Korea, Republic of

Paik Hospital; 🇰🇷 Pusan, Korea, Republic of

Dong-A University Hospital; 🇰🇷 Pusan, Korea, Republic of

Kosin University Gospel 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, Korea, Republic of