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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01903902
Recruitment Status : Unknown
Verified July 2013 by Woong Chol Kang, Gachon University Gil Medical Center.
Recruitment status was:  Recruiting
First Posted : July 19, 2013
Last Update Posted : July 19, 2013
Sponsor:
Collaborators:
Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Inje University
Chonnam National University Hospital
Ulsan University Hospital
Jeju National University Hospital
Daegu Catholic University Medical Center
Chungbuk National University
Dankook University
The Catholic University of Korea
Kwandong University Myongji Hospital
Kosin University Gospel Hospital
Keimyung University Dongsan Medical Center
Soonchunhyang University Hospital
National Health Insurance Service Ilsan Hospital
Saint Carollo General Hospital
Chuncheon Sacred Heart Hospital
Sejong General Hospital
Cheju Halla General Hospital
Wonkwang University
Konyang University Hospital
Gangnam Severance Hospital
Hallym University Medical Center
Chonbuk National University Hospital
Korea University Guro Hospital
Information provided by (Responsible Party):
Woong Chol Kang, Gachon University Gil Medical Center

Brief 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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Device: SeQuent® Please Drug-eluting balloon Phase 4

Detailed Description:

Drug-eluting balloon (DEB) have emerged as a potential alternative to overcome the limitations of drug-eluting stents such as restenosis or stent thrombosis.

DEB angioplasty is proven to be effective clinically for the treatment of in-stent restenosis. However, DEB for de novo lesions, especially in small vessels is less studied.

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Efficacy and Safety of Paclitaxel-eluting SeQuent Please Drug-Eluting Balloon for Treatment of lesiOns in Native smalL coronarY Arteries (DEB-ONLY)
Study Start Date : June 2013
Estimated Primary Completion Date : June 2015
Estimated Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Paclitaxel

Arm Intervention/treatment
Experimental: Drug-eluting balloon
Balloon angioplasty using paclitaxel-eluting SeQuent Please drug-eluting balloon in native small coronary artery (vessel diameter > 2.25 mm and ≤ 2.75 mm)
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.




Primary Outcome Measures :
  1. Late loss [ Time Frame: 9±1 months ]
    Late loss of the target lesion at the follow-up (9±1 months) quantitative coronary

  2. Binary restenosis rate [ Time Frame: 9±1 months ]
    Restenosis rate of the target lesion at the follow-up quantitative coronary angiography


Secondary Outcome Measures :
  1. Neointimal hyperplasia [ Time Frame: 9±1 months ]
    Neointimal hyperplasia of the target lesion at the follow-up intravascular ultrasound (IVUS) or optical coherence tomography (OCT) exam

  2. Clinical outcomes [ Time Frame: 9±1 months ]
    Clinical outcomes including death, myocardial infarct, target lesion revascularization, stent thrombosis within the target lesion



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 19 years
  • Patients who are appropriate for percutaneous coronary intervention using drug-eluting balloon in native small coronary artery (vessel diameter ≥ 2.25 mm and ≤ 2.75 mm, lesion length < 25 mm)
  • Informed consent

Exclusion Criteria:

  • Chronic total obstruction lesion
  • Severe calcified lesion
  • Left main coronary lesion
  • Lesion having intravascular thrombus
  • Shock status from any cause including cardiogenic shock
  • Left ventricular ejection fraction < 30%
  • Need for coronary artery bypass surgery
  • Allergic reaction for paclitaxel
  • Severe allergic for contrast agent (Visipaque) or statin
  • Pregnancy, breastfeeding or Expectation for pregnancy in women of childbearing age

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01903902


Contacts
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Contact: Woong Chul Kang, M.D. +82-32-460-3663 kangwch@gilhospital.com

Locations
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Korea, Republic of
Gachon University Gil Medical Center Recruiting
Incheon, Korea, Republic of, 405-760
Contact: Woong Chul Kang, M.D.    +82-32-460-3663    kangwch@gilhospital.com   
Principal Investigator: Woong Chul Kang, M.D.         
Sponsors and Collaborators
Gachon University Gil Medical Center
Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Inje University
Chonnam National University Hospital
Ulsan University Hospital
Jeju National University Hospital
Daegu Catholic University Medical Center
Chungbuk National University
Dankook University
The Catholic University of Korea
Kwandong University Myongji Hospital
Kosin University Gospel Hospital
Keimyung University Dongsan Medical Center
Soonchunhyang University Hospital
National Health Insurance Service Ilsan Hospital
Saint Carollo General Hospital
Chuncheon Sacred Heart Hospital
Sejong General Hospital
Cheju Halla General Hospital
Wonkwang University
Konyang University Hospital
Gangnam Severance Hospital
Hallym University Medical Center
Chonbuk National University Hospital
Korea University Guro Hospital
Investigators
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Principal Investigator: Woong Chul Kang, M.D. Gachon University Gil Medical Center

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Responsible Party: Woong Chol Kang, Associate Professor, Gachon University Gil Medical Center
ClinicalTrials.gov Identifier: NCT01903902     History of Changes
Other Study ID Numbers: DEB-ONLY
First Posted: July 19, 2013    Key Record Dates
Last Update Posted: July 19, 2013
Last Verified: July 2013

Keywords provided by Woong Chol Kang, Gachon University Gil Medical Center:
Coronary artery disease
Balloon angioplasty
Drug-eluting balloon

Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action