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

Study Overview
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Brief Summary
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This study was designed to verify the safety and efficacy of Lepu® Drug Coated Balloon in Treatment of Coronary Small-vessel Disease

Detailed Description
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This study include a small vessel cohort and a very small vessel cohort. In the small vessel cohort, patients with visually estimated reference vessel diameters(RVDs)≥2.0 and ≤2.75mm were randomly assigned to the Coronary Drug Coated Balloon Catheter Used in Small Vessels of Lepu Medical or the Restore DEB in a 1:1 ratio. The study was powered to detect the noninferiority of the DCB of Lepu Medical versus the Restore DEB for a primary endpoint of in-segment late lumen loss(LLL) at 9 months. In the very small vessel cohort, patients with RVD≥1.75 and<2.0mm were treated with the DCB of Lepu Medical of an appropriate size. All subjects will been followed up for 2 years to observe the occurrence of adverse events, so as to make an accurate and reliable evaluation of the safety of drug coated balloon catheters for coronary small vessels.

Official Title
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Assess the Safety and Efficacy of Lepu® Drug Coated Balloon Versus RESTORE® Paclitaxel Eluting Balloon for the Treatment of Coronary Small-vessel Disease: a Prospective, Multicenter, Randomized, Controlled Trial

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: DCB of Lepu Medical(dimeter≥2.00 mm)
* Device: Restore DEB
* Device: DCB of Lepu Medical(dimeter<2.00 mm)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: small vessel cohort: DCB of Lepu Medical<br>receiving the treatment with DCB of Lepu Medical(dimeter≥2.00 mm) in small vessel cohort | Device: DCB of Lepu Medical(dimeter≥2.00 mm)<br>* subjects receiving DCB of Lepu Medical(dimeter≥2.00 mm)<br>* Other names: Coronary Drug Coated Balloon Catheter of Lepu Medical for coronary small vessels;|
| Active Comparator: small vessel cohort:Restore DEB<br>receiving the treatment with Restore DEB in small vessel cohort | Device: Restore DEB<br>* subjects receiving Restore DEB<br>* Other names: RESTORE Paclitaxel releasing coronary balloon catheter;|
| Other: very small vessel cohort: DCB of Lepu Medical<br>receiving the treatment with DCB of Lepu Medical(dimeter<2.00 mm) in very small vessel cohort | Device: DCB of Lepu Medical(dimeter<2.00 mm)<br>* subjects receiving DCB of Lepu Medical(dimeter<2.00 mm)<br>* Other names: Coronary Drug Coated Balloon Catheter of Lepu Medical for coronary very small vessels;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In-segment late lumen loss(LLL) | In-segment late lumen loss is defined as the change in minimal lumen diameter | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The success rate of intervention treatment (%)(Device success,Lesion success ,Procedural success) | The success rate of intervention treatment (%) include device success,lesion success and procedural success | 2-3 days | 
| In-segment diameter stenosis(DS%) | In-segment diameter stenosis(DS%) defined as (1-minimal luminal diameter[MLD]/reference vessel diameter[RVD])*100%. | 9 months | 
| Angiographic binary restenosis (ABR) | Angiographic binary restenosis (ABR), defined as target lesion DS ≥ 50% at follow up | 9 months | 
| Target lesion failure (TLF) | Target lesion failure (TLF), including cardiac death, target vessel-myocardial infarction (MI), or ischemic-driven target lesion revascularization (ID-TLR) | 30 days,6,9 months,and 1,2 years | 
| Patient-oriented composite endpoint (PoCE) | Patient-oriented composite endpoint (PoCE), including all-cause death, all MI, or any revascularization. | 30 days,6,9 months,and 1,2 years | 
| Definite or probable target lesion thrombosis | Definite or probable target lesion thrombosis, including Acute stent thrombosis, Early stent thrombosis, Late stent thrombosis, Very late stent thrombosis | 30 days,6,9 months,and 1,2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Drug Coated Balloon Catheter, Small Coronary Vessel Disease, Randomized Controlled Trial