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

Chonnam National University

Status: Completed

Conditions: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease

Treatments: Device: Zotarolimus-Eluting Stent

Study type: Observational

Funder types: Other

Identifiers

NCT04825886

CNUH-2017-319

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,000 patients

Sex: All

Ages: 19+ years old

Volunteers: No 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