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

Gachon University Gil Medical Center

Status and phase: Unknown; Phase 4

Conditions: Coronary Artery Disease

Treatments: Device: SeQuent® Please Drug-eluting balloon

Study type: Interventional

Funder types: Other

Identifiers

NCT01903902

DEB-ONLY

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,000 participants in 1 patient group

Drug-eluting balloon

Experimental group

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)

Treatment:

Device: SeQuent® Please Drug-eluting balloon