Clinical trial NCT01903902: 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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Coronary Artery Disease
Keywords: Coronary artery disease
Balloon angioplasty
Drug-eluting balloon
Lead sponsor: Gachon University Gil Medical Center
Sponsor class: OTHER
Collaborators: name: Chung-Ang University Hosptial, Chung-Ang University College of Medicine
name: Inje University
name: Chonnam National University Hospital
name: Ulsan University Hospital
name: Jeju National University Hospital
name: Daegu Catholic University Medical Center
name: Chungbuk National University
name: Dankook University
name: The Catholic University of Korea
name: Kwandong University Myongji Hospital
name: Kosin University Gospel Hospital
name: Keimyung University Dongsan Medical Center
name: Soonchunhyang University Hospital
name: National Health Insurance Service Ilsan Hospital
name: Saint Carollo General Hospital
name: Chuncheon Sacred Heart Hospital
name: Sejong General Hospital
name: Cheju Halla General Hospital
name: Wonkwang University
name: Konyang University Hospital
name: Gangnam Severance Hospital
name: Hallym University Medical Center
name: Chonbuk National University Hospital
name: Korea University Guro Hospital
First posted: 2013-07-19
Enrollment: 1000
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Late loss
timeFrame: 9±1 months
measure: Binary restenosis rate
timeFrame: 9±1 months
Secondary outcomes:
measure: Neointimal hyperplasia
timeFrame: 9±1 months
measure: Clinical outcomes
timeFrame: 9±1 months
Other outcomes:
Locations:
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
Study officials:
affiliation: Gachon University Gil Medical Center
name: Woong Chul Kang, M.D.
role: PRINCIPAL_INVESTIGATOR
References: