None listed
Conditions
Interventions
Medical Device : The Biomatrix and Nobori stents groups both elute biolimus A9 (15.6 µg/mm stent length), which is a lipophilic analogue of rapamycin, designed to be readily absorbed into the tissue.
Sponsors
Gachon University Gil Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) age >= 19 years (2) patients diagnosed with acute coronary syndrome (3) lesions with a reference diameter between 2.5 and 4.0 mm, where stent implantation was technically feasible (4) lesions with more than 50% stenosis; and (5) agreement to be enrolled after giving written informed consent
Exclusion criteria
Exclusion criteria: (1) chronic total obstruction lesions and in-stent restenosis lesions (2) cardiogenic shock or systolic blood pressure < 80 mmHg (3) impaired hepatic function, defined as liver cirrhosis or liver enzyme (aspartate aminotransferase or alanine aminotransferase) levels beyond 5-fold of normal limits (4) pregnancy, breastfeeding, or females planning pregnancy in the near future (5) patients with bleeding tendency (6) left ventricular ejection fraction = 25% (7) serum creatinine = 3.0 mg/dL (8) life expectancy < 1 year (9) allergic to antiplatelet medication (10) lack of suitability for enrollment, as determined by the investigator (11) a PCI procedure for an ISR or chronic total occlusion (CTO) lesion(s) within 6 months prior to enrollment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| major adverse cardiovascular events (MACE), defined as the composite of cardiac death, non-fatal myocardial infarction (MI), and target lesion revascularization (TLR). | — |
Secondary
| Measure | Time frame |
|---|---|
| Major cardiac and cerebrovascular events (MACCE), defined as a composite of all-cause death, MI, repeat revascularization (RR), and stroke | — |
Countries
Korea, Republic of
Contacts
Public ContactYoungwoo Jang
Gachon University Gil Medical Center
Outcome results
None listed