The NeoVas Bioresorbable Coronary Scaffold Randomized Controlled Trial is a prospective, multi-center, randomized trial. The study compares NeoVas sirolimus-eluting bioresorbable coronary scaffold with XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS) to evaluate the safety and efficacy of NeoVas in the treatment of patients with de novo coronary lesion.
Approximately 560 subjects will be randomly enrolled at a 1:1 ratio, patients in experimental group receiving NeoVas BCS(Lepu Medical Technology (Beijing) Co.,Ltd), and subjects in control group receiving XIENCE PRIME EECSS(Abbott Vascular, Inc). Subjects will have clinical follow-up at 30, 90, 180 and 270 days and at 1,2,3,4 and 5 years. All subjects will undergo coronary angiography at 1 year post-index procedure. The primary endpoint is in-segment late lumen loss(LLL) at 1 year follow-up. Among the RCT study, a subgroup study is designed to evaluate the functional recovery of vasomotion before and after the complete degradation of the NeoVas Bioresorbable Coronary Scaffold with the aid of angiography, OCT and FFR. The subgroup study will be performed in two centers and 160 subjects will be enrolled on a 1:1 randomization basis. Subjects will receive angiography and OCT examination before procedure, and will receive angiography, OCT and FFR after procedure and at 1, 3 years follow-up.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
560
Subjects receiving NeoVas BCS
Subjects receiving XIENCE PRIME EECSS
In-segment late lumen loss (LLL)
In-segment late loss is defined as the change in minimal lumen diameter (MLD) within the margins of the scaffold and 5 mm proximal and 5 mm distal to the scaffold from post-procedure to 1 year by angiography.
Time frame: 1 year
Major secondary endpoint: Percentage of patients who experienced angina within 1 year
Angina is defined as any angina or angina equivalent symptoms determined by the physician and/or research coordinator after interview of the patient, and as adjudicated by a clinical events committee (CEC).
Time frame: From 7 days post-procedure to 1 year
Device Success
Successful delivery and deployment of the assigned scaffold at the intended target lesion and successful withdrawal of the delivery system with attainment of final in-scaffold residual stenosis of less than 30% by quantitative coronary angiography (QCA) (by visual estimation if QCA unavailable). The success or failure of the first-aid stent is not included.
Time frame: intraoperative
Procedural Success
Achievement of final in-scaffold residual stenosis of less than 30% by QCA (by visual estimation if QCA unavailable) with successful delivery and deployment of at least one assigned scaffold at the intended target lesion and successful withdrawal of the delivery system for the target lesion without the occurrence of cardiac death, target vessel MI or repeat TLR. For the circumstance of two target lesions, both lesions must meet the success criteria.
Time frame: At time of procedure up to 7 days in hospital
Target lesion failure(TLF)
Target lesion failure is a composite endpoint of cardiac death, target vessel related myocardial infarction (TV-MI) and the ischemia-driven target lesion revascularization.
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Anhui Provincial Hospital
Hefei, Anhui, China
Beijing Anzhen Hospital, Capital Medical University
Beijing, Beijing Municipality, China
General Hospital of Armed Police Forces
Beijing, Beijing Municipality, China
Aerospace Center Hospital
Beijing, Beijing Municipality, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
The First Hospital of Lanzhou University
Lanzhou, Gansu, China
Nanfang Hospital Southern Medical University
Guangzhou, Guangdong, China
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China
Bethune Peace Hospital of PLA
Shijiazhuang, Hebei, China
Renmin Hospital of Wuhan University
Wuhan, Hubei, China
...and 17 more locations
Time frame: 30days, 3,6,9 months and 1,2,3,4,5 years
Ischemia-driven Target Lesion Revascularization (iTLR)
Time frame: 30 days, 3,6,9 months and 1, 2, 3, 4, 5 years
Ischemia-driven Target Vessel Revascularization (iTVR)
Time frame: 30 days, 3,6,9 months and 1, 2, 3, 4, 5 years
All coronary revascularization (PCI and CABG)
percutaneous coronary intervention (PCI) coronary artery bypass graft (CABG)
Time frame: 30 days, 3,6,9 months and 1, 2, 3, 4, 5 years
Scaffold thrombosis
Scaffold thrombosis will be categorized as acute (≤1day), subacute (\>1day ≤30 days) and late (\>30 days).Clinical presentation of acute coronary syndrome with angiographic evidence of scaffold thrombosis (angiographic appearance of thrombus within or adjacent to a previously treated target lesion).In the absence of angiography, any unexplained death, or acute MI (ST segment elevation or new Q-wave) in the distribution of the target lesion within 30 days.
Time frame: 30days, 3,6,9 months and 1, 2, 3, 4, 5 years
Percentage of patients who experienced angina
Angina is defined as any angina or angina equivalent symptoms determined by the physician and/or research coordinator after interview of the patient, and as adjudicated by a clinical events committee (CEC).
Time frame: 30days, 3,6,9 months and 2, 3, 4, 5 years
Patient oriented composite endpoint
Patients oriented composite endpoint includes all-cause death, all myocardial infarction and any revascularization.
Time frame: 30 days, 3,6,9 months and 1, 2, 3, 4, 5 years