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

Phase 1

Withdrawn

• Conditions: Coronary Artery Disease
• Interventions: Device: H-side branch stent

• Registration Number: NCT02037386
• Lead Sponsor: Yonsei University

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2014-01-13
• Study First Submitted QC: 2014-01-14
• Study First Posted: 2014-01-15
• Study Start: 2014-02
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-07
• Last Update Posted: 2015-01-09

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
H-side branch stent	H-side branch stent	H-side branch stent group

Primary Outcome Measures

Name	Time	Method
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