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.

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.

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