Coronary Artery Disease
Conditions
Keywords
Side branch stent, Coronary bifurcation lesion
Brief summary
Intervention for coronary bifurcation lesion is about 10\ 20% of entire percutaneous coronary intervention (PCI). Bifurcation lesion is difficult to be treated and prognosis of PCI at bifurcation lesion has been poorer compared to that at non-bifurcation lesion. Furthermore, occlusion of side branch frequently occurred during PCI. Several techniques to prevent occlusion of side branch have been developed, but outcomes are not to be satisfied. H-side branch stent is developed to treat coronary side branch lesion and composed of proximal, connecting and distal parts. In vivo study performed in pigs showed effective H-side branch stent. This study is to confirm safety and efficacy of H-side branch stent for treatment of coronary side branch lesion.
Interventions
DEVICEH-side branch stent
Implantation of H-side branch stent at coronary bifurcation stenotic lesion
Sponsors
Yonsei University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Older than 20 years old * Patient with angina or asymptomatic ischemic cardiomyopathy who is required to be treated with stent at coronary bifurcation lesion * Bifurcation lesion with 2.5\ 4.0mm of main vessel diameter, \<30mm of main vessel length and ≥2.0mm of branched vessel diameter
Exclusion criteria
* Acute myocardial infarction * Confirmed or suspicious presence of thrombus in target lesion * In-stent restenosis lesion * Visual angulation with ≥75° * Lesion with severe calcification or severe tortuosity * Left main lesion * Chronic total occlusion lesion * Graft lesion * Contraindication to antiplatelet drugs * Left ventricular dysfunction (LVEF ≤40%) * Severe hepatic dysfunction (≥2.5 times than reference of AST or ALT) * Renal dysfunction (serum Creatinine \> 2.0mg/dL) * History of cerebral hemorrhage, pulmonary or gastrointestinal bleeding * Hypersensitivity of aspirin, clopidogrel or contrast media * Pregnant woman or possibility of pregnancy during clinical study period
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major adverse cardiovascular events | During 6 months after implantation of H-side branch stent | composite of cardiovascular death, non-fatal myocardial infarction, stent thrombosis, target lesion revascularization |
Outcome results
None listed