Efficacy and Safety of Paclitaxel-eluting Balloon for Treatment of Lesions in Native Small Coronary Arteries

Summary

The purpose of this study is to evaluate the efficacy and safety of paclitaxel-eluting balloon (SeQuent® Please) for treatment of lesions in native small coronary arteries.

Conditions

• Coronary Artery Disease

Interventions

DEVICE

SeQuent® Please Drug-eluting balloon

Balloon angioplasty using paclitaxel-eluting balloon (SeQuent® Please) will be done in native small coronary artery (vessel diameter ≥ 2.25 mm and ≤ 2.75 mm, and lesion length \< 25 mm), if residual stenosis is ≤ 30% and there are no dissection of classification C and over which disturbed blood flow after plain balloon angioplasty.

Sponsors & Collaborators

• Chung-Ang University Hosptial, Chung-Ang University College of Medicine

  collaborator OTHER

• Inje University

  collaborator OTHER

• Chonnam National University Hospital

  collaborator OTHER

• Ulsan University Hospital

  collaborator OTHER

• Jeju National University Hospital

  collaborator OTHER

• Daegu Catholic University Medical Center

  collaborator OTHER

• Chungbuk National University

  collaborator OTHER

• Dankook University

  collaborator OTHER

• The Catholic University of Korea

  collaborator OTHER

• Kwandong University Myongji Hospital

  collaborator UNKNOWN

• Kosin University Gospel Hospital

  collaborator OTHER

• Keimyung University Dongsan Medical Center

  collaborator OTHER

• Soonchunhyang University Hospital

  collaborator OTHER

• National Health Insurance Service Ilsan Hospital

  collaborator OTHER

• Saint Carollo General Hospital

  collaborator UNKNOWN

• Chuncheon Sacred Heart Hospital

  collaborator OTHER

• Sejong General Hospital

  collaborator OTHER

• Cheju Halla General Hospital

  collaborator OTHER

• Wonkwang University

  collaborator OTHER

• Konyang University Hospital

  collaborator OTHER

• Gangnam Severance Hospital

  collaborator OTHER

• Hallym University Medical Center

  collaborator OTHER

• Chonbuk National University Hospital

  collaborator OTHER

• Korea University Guro Hospital

  collaborator OTHER

• Gachon University Gil Medical Center

  lead OTHER

Principal Investigators

• Woong Chul Kang, M.D. · Gachon University Gil Medical Center

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

19 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-06-30

Primary Completion

2015-06-30

Completion

2015-06-30

Countries

• South Korea

Study Locations