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

Coronary Artery Disease Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01903902
• Other study ID #: DEB-ONLY
• Status: Recruiting
• Phase: Phase 4
• First received: July 17, 2013
• Last updated: July 18, 2013
• Start date: June 2013
• Est. completion date: June 2015

Study information

• Verified date: July 2013
• Source: Gachon University Gil Medical Center
• Contact: Woong Chul Kang, M.D.
• Phone: +82-32-460-3663
• Email: kangwch[@]gilhospital.com
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Gachon University Gil Medical Center	Incheon

Sponsors (25)

Lead Sponsor

Collaborator

Gachon University Gil Medical Center

Cheju Halla General Hospital, Chonbuk National University Hospital, Chonnam National University Hospital, Chuncheon Sacred Heart Hospital, Chung-Ang University Hospital, Chungbuk National University, Daegu Catholic University Medical Center, Dankook University, Gangnam Severance Hospital, Hallym University Medical Center, Inje University, Jeju National University Hospital, Keimyung University Dongsan Medical Center, Konyang University Hospital, Korea University Guro Hospital, Kosin University Gospel Hospital, Kwandong University Myongji Hospital, National Health Insurance Service Ilsan Hospital, Saint Carollo General Hospital, Sejong General Hospital, Soonchunhyang University Hospital, The Catholic University of Korea, Ulsan University Hospital, Wonkwang University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Late loss	Late loss of the target lesion at the follow-up (9±1 months) quantitative coronary	9±1 months	No
Primary	Binary restenosis rate	Restenosis rate of the target lesion at the follow-up quantitative coronary angiography	9±1 months	No
Secondary	Neointimal hyperplasia	Neointimal hyperplasia of the target lesion at the follow-up intravascular ultrasound (IVUS) or optical coherence tomography (OCT) exam	9±1 months	No
Secondary	Clinical outcomes	Clinical outcomes including death, myocardial infarct, target lesion revascularization, stent thrombosis within the target lesion	9±1 months	Yes