Clinical trial NCT04825886: Efficacy and Safety of ZotaRolimus-Eluting Coronary Stent System In Patients With Long Coronary Artery Disease
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Keywords: Coronary Artery Disease
Zotarolimus-Eluting Stent
Long Coronary Artery Disease
Target lesion failure
Lead sponsor: Chonnam National University Hospital
Sponsor class: OTHER
First posted: 2021-04-01
Enrollment: 2000
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Coronary artery disease

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.

Eligibility criteria: 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

Primary outcomes:
measure: Target lesion failure
timeFrame: Index admission to 12 months
Secondary outcomes:
measure: All-cause death
timeFrame: Index admission, 1 month, 6 months, 12 months
measure: Cardiac death
timeFrame: Index admission, 1 month, 6 months, 12 months
measure: Myocardial Infarction
timeFrame: Index admission, 1 month, 6 months, 12 months
measure: All-cause death or Myocardial infarction
timeFrame: Index admission, 1 month, 6 months, 12 months
measure: Cardiac death or Myocardial infarction
timeFrame: Index admission, 1 month, 6 months, 12 months
measure: Target vessel revascularization
timeFrame: Index admission, 1 month, 6 months, 12 months
measure: Target lesion revascularization
timeFrame: Index admission, 1 month, 6 months, 12 months
measure: Stent thrombosis
timeFrame: Index admission, 1 month, 6 months, 12 months
Other outcomes:
Locations:
city: Changwon
country: Korea, Republic of
facility: Gyeongsang National University Changwon Hospital
city: Cheonan
country: Korea, Republic of
facility: Dankook University Hospital
city: Chungju
country: Korea, Republic of
facility: Konkuk University Medical Center
city: Daegu
country: Korea, Republic of
facility: Daegu Catholic University Hospital
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Medical Center
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Hospital
city: Daegu
country: Korea, Republic of
facility: Yeungnam University Medical Center
city: Daejeon
country: Korea, Republic of
facility: Eulji Medical Center
city: Daejeon
country: Korea, Republic of
facility: Kongyang Univeristy Hospital
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
city: Gwangju
country: Korea, Republic of
facility: Chosun University Hospital
city: Iksan
country: Korea, Republic of
facility: Wongkwang University Hospital
city: Jeonju
country: Korea, Republic of
facility: Jeonbuk National University Hospital
city: Jeonju
country: Korea, Republic of
facility: Presbyterian Medical Center
city: Pusan
country: Korea, Republic of
facility: Dong-A University Hospital
city: Pusan
country: Korea, Republic of
facility: Kosin University Gospel Hospital
city: Pusan
country: Korea, Republic of
facility: Paik Hospital
city: Pusan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Suncheon
country: Korea, Republic of
facility: Saint Carollo Hospital
city: Yangsan
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
Study officials:
affiliation: Chonnam National University Hospital
name: Youngkeun Ahn, MD
role: PRINCIPAL_INVESTIGATOR
References: