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

January 7, 2015 updated by: Yonsei University
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: H-side branch stent
H-side branch stent group
Device: H-side branch stent
Implantation of H-side branch stent at coronary bifurcation stenotic lesion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major adverse cardiovascular events
Time Frame: During 6 months after implantation of H-side branch stent
composite of cardiovascular death, non-fatal myocardial infarction, stent thrombosis, target lesion revascularization
During 6 months after implantation of H-side branch stent

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

January 13, 2014

First Submitted That Met QC Criteria

January 14, 2014

First Posted (Estimate)

January 15, 2014

Study Record Updates

Last Update Posted (Estimate)

January 9, 2015

Last Update Submitted That Met QC Criteria

January 7, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1-2011-0096

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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