A Safety and Efficacy Study of Lepu® Drug Coated Balloon in Treatment of Coronary Small-vessel Disease
- Conditions
- Coronary Artery Disease
- Interventions
- Device: DCB of Lepu Medical(dimeter<2.00 mm)Device: Restore DEBDevice: DCB of Lepu Medical(dimeter≥2.00 mm)
- Registration Number
- NCT04953117
- Lead Sponsor
- Lepu Medical Technology (Beijing) Co., Ltd.
- Brief Summary
This study was designed to verify the safety and efficacy of Lepu® Drug Coated Balloon in Treatment of Coronary Small-vessel Disease
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 286
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description very small vessel cohort: DCB of Lepu Medical DCB of Lepu Medical(dimeter<2.00 mm) receiving the treatment with DCB of Lepu Medical(dimeter\<2.00 mm) in very small vessel cohort small vessel cohort:Restore DEB Restore DEB receiving the treatment with Restore DEB in small vessel cohort small vessel cohort: DCB of Lepu Medical DCB of Lepu Medical(dimeter≥2.00 mm) receiving the treatment with DCB of Lepu Medical(dimeter≥2.00 mm) in small vessel cohort
- Primary Outcome Measures
Name Time Method In-segment late lumen loss(LLL) 9 months In-segment late lumen loss is defined as the change in minimal lumen diameter
- Secondary Outcome Measures
Name Time Method The success rate of intervention treatment (%)(Device success,Lesion success ,Procedural success) 2-3 days The success rate of intervention treatment (%) include device success,lesion success and procedural success
Definite or probable target lesion thrombosis 30 days,6,9 months,and 1,2 years Definite or probable target lesion thrombosis, including Acute stent thrombosis, Early stent thrombosis, Late stent thrombosis, Very late stent thrombosis
In-segment diameter stenosis(DS%) 9 months In-segment diameter stenosis(DS%) defined as (1-minimal luminal diameter\[MLD\]/reference vessel diameter\[RVD\])\*100%.
Angiographic binary restenosis (ABR) 9 months Angiographic binary restenosis (ABR), defined as target lesion DS ≥ 50% at follow up
Target lesion failure (TLF) 30 days,6,9 months,and 1,2 years Target lesion failure (TLF), including cardiac death, target vessel-myocardial infarction (MI), or ischemic-driven target lesion revascularization (ID-TLR)
Patient-oriented composite endpoint (PoCE) 30 days,6,9 months,and 1,2 years Patient-oriented composite endpoint (PoCE), including all-cause death, all MI, or any revascularization.
Trial Locations
- Locations (14)
Inner Mongolia People's Hospital
🇨🇳Hohhot, Neimenggu, China
The Second Affiliated Hospital of Zhejiang University School of Medicine
🇨🇳Hangzhou, Zhejiang, China
Fujian Medical University Union Hospital
🇨🇳Fuzhou, Fujian, China
Peking University Third Hospital
🇨🇳Beijing, Beijing, China
The First Hospital of Hebei Medical University
🇨🇳Shijiazhuang, Hebei, China
No.980 Hospital of Joint Logistics Support Force
🇨🇳Shijiazhuang, Hebei, China
Sir Run Run Shaw Hospital,School of Medicine
🇨🇳Hangzhou, Zhejiang, China
Beijing Anzhen Hospital, Capital Medical University
🇨🇳Beijing, Beijing, China
Beijing Chao-Yang Hospital, Cpaital Medical University
🇨🇳Beijing, Beijing, China
Daqing Oilfield General Hospital
🇨🇳Daqing, Heilongjiang, China
Peking University Shougang Hospital
🇨🇳Beijing, Beijing, China
The Second Hospital of Jilin University
🇨🇳Chang chun, Jilin, China
Tianjin Medical University General Hospital
🇨🇳Tianjin, Tianjin, China
Beijing Friendship Hospital, Capital Medical University
🇨🇳Beijing, Beijing, China