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

NCT ID: NCT02037386

Last Updated: 2015-01-09

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2014-06-30

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.

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

H-side branch stent

H-side branch stent group

Group Type: EXPERIMENTAL

H-side branch stent

Intervention Type: DEVICE

Implantation of H-side branch stent at coronary bifurcation stenotic lesion

Interventions

H-side branch stent

Implantation of H-side branch stent at coronary bifurcation stenotic lesion

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

Hong MK, Shim JM, Youn YJ, Lee KH, Kim JS, Ko YG, Lee SH, Choi D, Yoon J, Jang Y. A new stent design for the treatment of true bifurcation lesions: H-side branch stents. J Interv Cardiol. 2010 Feb;23(1):54-9. doi: 10.1111/j.1540-8183.2009.00519.x. Epub 2009 Dec 17.

Reference Type: BACKGROUND

PMID: 20040003 (View on PubMed)

Other Identifiers

1-2011-0096

Identifier Type: -

Identifier Source: org_study_id