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

Yonsei University

Status and phase: Withdrawn; Phase 1

Conditions: Coronary Artery Disease

Treatments: Device: H-side branch stent

Study type: Interventional

Funder types: Other

Identifiers

NCT02037386

1-2011-0096

Details and patient eligibility

About

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.

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

H-side branch stent

Experimental group

Description:

H-side branch stent group

Treatment:

Device: H-side branch stent