A Safety and Efficacy Study of Lepu® Drug Coated Balloon in Treatment of Coronary Small-vessel Disease

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Drug Coated Balloon Catheter, Small Coronary Vessel Disease, Randomized Controlled Trial Read More

Inclusion Criteria:

• Age must be 18-80 years, males or females.
• Subject with stable angina, or unstable angina, or recent myocardial infarction (myocardial infarction occurred more than 7 days before enrolled into the group), or asymptomatic myocardial ischemia with evidence
• Coronary angiopathy in situ with stenosis of more than 70% with visually estimated (or more than 50% combined with symptoms of ischemia, TIMI ≥ 1) in a vessel with visually estimated reference vessel diameter (RVD) ≥ 2.0 mm and ≤ 2.75 mm in small vessel group,and ≤ 26 mm in length or RVD ≥ 1.75 mm and < 2.0 mm in very small vessel group, and ≤ 16 mm in length.
• Target small vessel lesions are located on one or two different coronary arteries (RCA / LAD/ LCX). The number of target small vessel lesions on each coronary artery is no more than one, and each target small vessel lesion can only be treated with one test instrument
• The number of non-target lesions requiring early interventional treatment is no more than two, and the distance between them and target lesions must be > 10 mm; Successful treatment of non target lesions is required before subjects are randomized and the test equipment(DCB) cannot be used for the treatment.
• Subject can receive any type of coronary revascularization (including balloon angioplasty, stent implantation or coronary artery bypass grafting)
• Subject can understand the study objectives and voluntarily participate in and sign the informed consent; subject must agree to clinical follow-up and angiographic follow-up at 9 months.

Exclusion Criteria:

• AMI within 1 week.
• In stent restenosis, complete occlusion or severe calcification (unable to pre expand successfully with balloon)
• Left main artery disease or bifurcation disease with diameter >2.00mm requiring interventional treatment
• Evidence of massive thrombi in the target vessels
• Severe heart failure (NYHA IV)
• Severe renal failure (subject with GFR < 30ml / min or undergoing hemodialysis)
• Subject with vein graft restenosis after bypass surgery or severe heart valve disease
• Pregnant or nursing subjects
• Life expectancy less than 12 months
• Subject with bleeding tendency, history of active peptic ulcer, suffered stroke within the past 6 months, contraindications of antiplatelet preparation and anticoagulant treatment
• Subject is currently participating in another investigational drug or device study that has not yet completed its primary endpoint.
• Subject has undergone heart transplantation
• Known allergy to aspirin, clopidogrel, heparin, contrast media, and paclitaxel.
• The investigator judged that the subject's compliance is poor and can not complete the study as required.