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

Yonsei University logo

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Withdrawn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)

0 participants in 1 patient group

H-side branch stent
Experimental group
Description:
H-side branch stent group
Treatment:
Device: H-side branch stent

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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