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

NCT02037386 | Withdrawn Phase 1 DMC

• 1 other identifier: 1-2011-0096
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Keywords

Side branch stent; Coronary bifurcation lesion

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

H-side branch stent

EXPERIMENTAL

H-side branch stent group

Device: H-side branch stent

Interventions

H-side branch stent DEVICE

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

H-side branch stent

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

Related 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.

  PMID: 20040003 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2014
• First Posted: January 15, 2014
• Study Start: February 1, 2014
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: January 9, 2015

Record last verified: 2015-01