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

Sponsor

Chonnam National University Hospital (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04825886

Collaborator

(none)

2,000

Enrollment

Locations

60.1

Anticipated Duration (Months)

100

Patients Per Site

1.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease Myocardial Ischemia Coronary Disease	Device: Zotarolimus-Eluting Stent

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 Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

2000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Evaluation of Effectiveness and Safety of ZotaRolimus-Eluting Coronary Stent System In Patients With Long Coronary Artery Disease; A Multicenter, Prospective, Observational Registry Study

Actual Study Start Date :

Dec 28, 2017

Anticipated Primary Completion Date :

Aug 30, 2022

Anticipated Study Completion Date :

Dec 30, 2022

Outcome Measures

Primary Outcome Measures

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

All-cause death [Index admission, 1 month, 6 months, 12 months]
Cumulative incidence rate of all-cause death 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
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
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
Target vessel revascularization [Index admission, 1 month, 6 months, 12 months]
Cumulative incidence rate of target vessel revascularization at each visit
Target lesion revascularization [Index admission, 1 month, 6 months, 12 months]
Cumulative incidence rate of target lesion revascularization at each visit
Stent thrombosis [Index admission, 1 month, 6 months, 12 months]
Cumulative incidence rate of stent thrombosis at each visit

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country
1	Gyeongsang National University Changwon Hospital	Changwon	Korea, Republic of
2	Dankook University Hospital	Cheonan	Korea, Republic of
3	Konkuk University Medical Center	Chungju	Korea, Republic of
4	Daegu Catholic University Hospital	Daegu	Korea, Republic of
5	Keimyung University Dongsan Medical Center	Daegu	Korea, Republic of
6	Kyungpook National University Hospital	Daegu	Korea, Republic of
7	Yeungnam University Medical Center	Daegu	Korea, Republic of
8	Eulji Medical Center	Daejeon	Korea, Republic of
9	Kongyang Univeristy Hospital	Daejeon	Korea, Republic of
10	Chonnam National University Hospital	Gwangju	Korea, Republic of
11	Chosun University Hospital	Gwangju	Korea, Republic of
12	Wongkwang University Hospital	Iksan	Korea, Republic of
13	Jeonbuk National University Hospital	Jeonju	Korea, Republic of
14	Presbyterian Medical Center	Jeonju	Korea, Republic of
15	Dong-A University Hospital	Pusan	Korea, Republic of
16	Kosin University Gospel Hospital	Pusan	Korea, Republic of
17	Paik Hospital	Pusan	Korea, Republic of
18	Pusan National University Hospital	Pusan	Korea, Republic of
19	Saint Carollo Hospital	Suncheon	Korea, Republic of
20	Pusan National University Yangsan Hospital	Yangsan	Korea, Republic of