Coronary Artery Disease, Myocardial Ischemia, Coronary Disease
Conditions
Keywords
Coronary Artery Disease, Zotarolimus-Eluting Stent, Long Coronary Artery Disease, Target lesion failure
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.
Interventions
Percutaneous coronary intervention using zotarolimus-eluting stent
Sponsors
Chonnam National University Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| All-cause death | Index admission, 1 month, 6 months, 12 months | Cumulative incidence rate of all-cause death 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 |
| 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 |
Countries
South Korea
Outcome results
None listed