The Efficacy and Safety of Paclitaxel-eluting SeQuent Please Drug-Eluting Balloon for Treatment of lesiOns in Native smalL coronarY Arteries (DEB-ONLY)
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Coronary Artery Disease
- Sponsor
- Gachon University Gil Medical Center
- Enrollment
- 1000
- Locations
- 1
- Primary Endpoint
- Late loss
- Last Updated
- 12 years ago
Overview
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.
Investigators
Woong Chol Kang
Associate Professor
Gachon University Gil Medical Center
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
Outcomes
Primary Outcomes
Late loss
Time Frame: 9±1 months
Late loss of the target lesion at the follow-up (9±1 months) quantitative coronary
Binary restenosis rate
Time Frame: 9±1 months
Restenosis rate of the target lesion at the follow-up quantitative coronary angiography
Secondary Outcomes
- Neointimal hyperplasia(9±1 months)
- Clinical outcomes(9±1 months)