This study was designed to verify the safety and efficacy of Lepu® Drug Coated Balloon in Treatment of Coronary Small-vessel Disease
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
286
subjects receiving DCB of Lepu Medical(dimeter≥2.00 mm)
subjects receiving Restore DEB
subjects receiving DCB of Lepu Medical(dimeter\<2.00 mm)
Beijing Anzhen Hospital, Capital Medical University
Beijing, Beijing Municipality, China
RECRUITINGPeking University Third Hospital
In-segment late lumen loss(LLL)
In-segment late lumen loss is defined as the change in minimal lumen diameter
Time frame: 9 months
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
Time frame: 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%.
Time frame: 9 months
Angiographic binary restenosis (ABR)
Angiographic binary restenosis (ABR), defined as target lesion DS ≥ 50% at follow up
Time frame: 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)
Time frame: 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.
Time frame: 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
Time frame: 30 days,6,9 months,and 1,2 years
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Beijing, Beijing Municipality, China
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China
RECRUITINGBeijing Chao-Yang Hospital, Cpaital Medical University
Beijing, Beijing Municipality, China
RECRUITINGPeking University Shougang Hospital
Beijing, Beijing Municipality, China
RECRUITINGFujian Medical University Union Hospital
Fuzhou, Fujian, China
RECRUITINGThe First Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
RECRUITINGNo.980 Hospital of Joint Logistics Support Force
Shijiazhuang, Hebei, China
RECRUITINGDaqing Oilfield General Hospital
Daqing, Heilongjiang, China
RECRUITINGThe Second Hospital of Jilin University
Changchun, Jilin, China
RECRUITING...and 4 more locations