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

Coronary Artery Disease Clinical Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02037386
• Other study ID #: 1-2011-0096
• Status: Withdrawn
• Phase: Phase 1
• First received: January 13, 2014
• Last updated: January 7, 2015
• Start date: February 2014
• Est. completion date: June 2014

Study information

• Verified date: January 2015
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No