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

Phase 4

• Conditions: Coronary Artery Disease
• Interventions: Device: SeQuent® Please Drug-eluting balloon

• Registration Number: NCT01903902
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2013-06
• Status Verified: 2013-07
• Study First Submitted: 2013-07-17
• Study First Submitted QC: 2013-07-18
• Last Update Submitted: 2013-07-18
• Study First Posted: 2013-07-19
• Last Update Posted: 2013-07-19
• Primary Completion: 2015-06
• Study Completion: 2015-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Drug-eluting balloon	SeQuent® Please 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)

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Gachon University Gil Medical Center; 🇰🇷 Incheon, Korea, Republic of