H-Side Branch Stent, A New Stent for the Treatment of True Bifurcation Lesions

Study Overview
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Brief Summary
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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.

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: H-side branch stent


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: H-side branch stent<br>H-side branch stent group | Device: H-side branch stent<br>* Implantation of H-side branch stent at coronary bifurcation stenotic lesion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major adverse cardiovascular events | composite of cardiovascular death, non-fatal myocardial infarction, stent thrombosis, target lesion revascularization | During 6 months after implantation of H-side branch stent | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Side branch stent, Coronary bifurcation lesion