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

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Efficacy and Safety of Paclitaxel-eluting SeQuent Please Drug-Eluting Balloon for Treatment of lesiOns in Native smalL coronarY Arteries (DEB-ONLY)

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: SeQuent® Please Drug-eluting balloon


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Drug-eluting balloon<br>Balloon angioplasty using paclitaxel-eluting SeQuent Please drug-eluting balloon in native small coronary artery (vessel diameter > 2.25 mm and ≤ 2.75 mm) | Device: SeQuent® Please Drug-eluting balloon<br>* Balloon angioplasty using paclitaxel-eluting balloon (SeQuent® Please) will be done in native small coronary artery (vessel diameter ≥ 2.25 mm and ≤ 2.75 mm, and lesion length < 25 mm), if residual stenosis is ≤ 30% and there are no dissection of classification C and over which disturbed blood flow after plain balloon angioplasty.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Late loss | Late loss of the target lesion at the follow-up (9±1 months) quantitative coronary | 9±1 months | 
| Binary restenosis rate | Restenosis rate of the target lesion at the follow-up quantitative coronary angiography | 9±1 months | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronary artery disease, Balloon angioplasty, Drug-eluting balloon