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

Primary Purpose

Coronary Artery Disease

Status

Unknown status

Phase

Phase 4

Locations

Korea, Republic of

Study Type

Interventional

Intervention

SeQuent® Please Drug-eluting balloon

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Coronary artery disease, Balloon angioplasty, Drug-eluting balloon

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Gachon University Gil Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Drug-eluting balloon

Arm Description

Balloon angioplasty using paclitaxel-eluting SeQuent Please drug-eluting balloon in native small coronary artery (vessel diameter > 2.25 mm and ≤ 2.75 mm)

Outcomes

Primary Outcome Measures

Late loss

Late loss of the target lesion at the follow-up (9±1 months) quantitative coronary

Binary restenosis rate

Restenosis rate of the target lesion at the follow-up quantitative coronary angiography

Secondary Outcome Measures

Neointimal hyperplasia

Neointimal hyperplasia of the target lesion at the follow-up intravascular ultrasound (IVUS) or optical coherence tomography (OCT) exam

Clinical outcomes

Clinical outcomes including death, myocardial infarct, target lesion revascularization, stent thrombosis within the target lesion

Full Information

NCT ID

NCT01903902

First Posted

July 17, 2013

Last Updated

July 18, 2013

Sponsor

Gachon University Gil Medical Center

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

1. Study Identification

Unique Protocol Identification Number

NCT01903902

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

July 2013

Overall Recruitment Status

Unknown status

Study Start Date

June 2013 (undefined)

Primary Completion Date

June 2015 (Anticipated)

Study Completion Date

June 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Gachon University Gil Medical Center

Collaborators

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronary Artery Disease

Keywords

Coronary artery disease, Balloon angioplasty, Drug-eluting balloon

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

1000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Drug-eluting balloon

Arm Type

Experimental

Arm Description

Balloon angioplasty using paclitaxel-eluting SeQuent Please drug-eluting balloon in native small coronary artery (vessel diameter > 2.25 mm and ≤ 2.75 mm)

Intervention Type

Device

Intervention Name(s)

SeQuent® Please Drug-eluting balloon

Intervention Description

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 Measure Information:

Title

Late loss

Description

Late loss of the target lesion at the follow-up (9±1 months) quantitative coronary

Time Frame

9±1 months

Title

Binary restenosis rate

Description

Restenosis rate of the target lesion at the follow-up quantitative coronary angiography

Time Frame

9±1 months

Secondary Outcome Measure Information:

Title

Neointimal hyperplasia

Description

Neointimal hyperplasia of the target lesion at the follow-up intravascular ultrasound (IVUS) or optical coherence tomography (OCT) exam

Time Frame

9±1 months

Title

Clinical outcomes

Description

Clinical outcomes including death, myocardial infarct, target lesion revascularization, stent thrombosis within the target lesion

Time Frame

9±1 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Woong Chul Kang, M.D.

Phone

+82-32-460-3663

kangwch@gilhospital.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Woong Chul Kang, M.D.

Organizational Affiliation

Gachon University Gil Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Gachon University Gil Medical Center

City

Incheon

ZIP/Postal Code

405-760

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Woong Chul Kang, M.D.

Phone

+82-32-460-3663

kangwch@gilhospital.com

First Name & Middle Initial & Last Name & Degree

Woong Chul Kang, M.D.

12. IPD Sharing Statement

Learn more about this trial

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

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