Clinical trial NCT04953117: A Safety and Efficacy Study of Lepu® Drug Coated Balloon in Treatment of Coronary Small-vessel Disease
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coronary Artery Disease
Keywords: Drug Coated Balloon Catheter
Small Coronary Vessel Disease
Randomized Controlled Trial
Lead sponsor: Lepu Medical Technology (Beijing) Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-07-07
Enrollment: 286
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: In-segment late lumen loss(LLL)
timeFrame: 9 months
Secondary outcomes:
measure: The success rate of intervention treatment (%)(Device success,Lesion success ,Procedural success)
timeFrame: 2-3 days
measure: In-segment diameter stenosis(DS%)
timeFrame: 9 months
measure: Angiographic binary restenosis (ABR)
timeFrame: 9 months
measure: Target lesion failure (TLF)
timeFrame: 30 days,6,9 months,and 1,2 years
measure: Patient-oriented composite endpoint (PoCE)
timeFrame: 30 days,6,9 months,and 1,2 years
measure: Definite or probable target lesion thrombosis
timeFrame: 30 days,6,9 months,and 1,2 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Anzhen Hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Friendship Hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Beijing Chao-Yang Hospital, Cpaital Medical University
state: Beijing
city: Beijing
country: China
facility: Peking University Shougang Hospital
state: Beijing
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital
state: Fujian
city: Shijiazhuang
country: China
facility: The First Hospital of Hebei Medical University
state: Hebei
city: Shijiazhuang
country: China
facility: No.980 Hospital of Joint Logistics Support Force
state: Hebei
city: Daqing
country: China
facility: Daqing Oilfield General Hospital
state: Heilongjiang
city: Chang chun
country: China
facility: The Second Hospital of Jilin University
state: Jilin
city: Hohhot
country: China
facility: Inner Mongolia People's Hospital
state: Neimenggu
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
state: Tianjin
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital,School of Medicine
state: Zhejiang
city: Hangzhou
country: China
facility: The Second Affiliated Hospital of Zhejiang University School of Medicine
state: Zhejiang
Study officials:
affiliation: Peking University Third Hospital
name: Yida Tang
role: STUDY_CHAIR
References: