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

The Efficacy and Safety of Paclitaxel-eluting SeQuent Please Drug-Eluting Balloon for Treatment of lesiOns in Native smalL coronarY Arteries (DEB-ONLY)

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.

Study Overview

• Status: Unknown
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: SeQuent® Please Drug-eluting balloon

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.

• Study Type: Interventional
• Enrollment (Anticipated): 1000
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Woong Chul Kang, M.D.; Phone Number: +82-32-460-3663; Email: kangwch@gilhospital.com

Study Locations

• Korea, Republic of
  • Incheon, Korea, Republic of, 405-760
    • Recruiting
    • Gachon University Gil Medical Center
    • Contact: Woong Chul Kang, M.D.; Phone Number: +82-32-460-3663; Email: kangwch@gilhospital.com
    • Principal Investigator: Woong Chul Kang, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Late loss	Late loss of the target lesion at the follow-up (9±1 months) quantitative coronary	9±1 months
Binary restenosis rate	Restenosis rate of the target lesion at the follow-up quantitative coronary angiography	9±1 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neointimal hyperplasia	Neointimal hyperplasia of the target lesion at the follow-up intravascular ultrasound (IVUS) or optical coherence tomography (OCT) exam	9±1 months
Clinical outcomes	Clinical outcomes including death, myocardial infarct, target lesion revascularization, stent thrombosis within the target lesion	9±1 months

Collaborators and Investigators

• Sponsor: Gachon University Gil Medical Center
• Collaborators: Chonbuk National University Hospital; Chonnam National University Hospital; Ulsan University Hospital; Korea University Guro Hospital; Daegu Catholic University Medical Center; Chung-Ang University Hosptial, Chung-Ang University College of Medicine; Inje University; The Catholic University of Korea; Gangnam Severance Hospital; Keimyung University Dongsan Medical Center; Chungbuk National University; Soonchunhyang University Hospital; Jeju National University Hospital; Hallym University Medical Center; Sejong General Hospital; Dankook University; Wonkwang University; Kosin University Gospel Hospital; Chuncheon Sacred Heart Hospital; National Health Insurance Service Ilsan Hospital; Konyang University Hospital; Kwandong University Myongji Hospital; Saint Carollo General Hospital; Cheju Halla General Hospital
• Investigators: Principal Investigator: Woong Chul Kang, M.D., Gachon University Gil Medical Center

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Anticipated): June 1, 2015
• Study Completion (Anticipated): June 1, 2015

Study Registration Dates

• First Submitted: July 17, 2013
• First Submitted That Met QC Criteria: July 18, 2013
• First Posted (Estimate): July 19, 2013

Study Record Updates

• Last Update Posted (Estimate): July 19, 2013
• Last Update Submitted That Met QC Criteria: July 18, 2013
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Keywords: Coronary artery disease; Drug-eluting balloon; Balloon angioplasty
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: DEB-ONLY