The NeoVas Bioresorbable Coronary Scaffold Registry Trial is a prospective, multi-center, single arm registry trial based on the NeoVas FIM study which verified the safety and effectiveness of NeoVas initially. This study is to evaluate the safety and effectiveness of NeoVas sirolimus-eluting bioresorbable coronary scaffold in the treatment of patients with de novo coronary lesion.
Approximately 825 subjects will be enrolled and receive NeoVas BCS(Lepu Medical Technology (Beijing) Co.,Ltd). Subjects will have clinical follow-up at 30, 90, 180 and 270 days and at 1,2,3,4 and 5 years. The primary endpoint is target lesion failure(TLF) at 1 year follow-up.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
825
Subjects receiving NeoVas BCS
Target lesion failure
Target lesion failure is a composite endpoint of cardiac death, target vessel related myocardial infarction (TV-MI) and the ischemia-driven target lesion revascularization.
Time frame: 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
Target lesion failure is a composite endpoint of cardiac death, target vessel related myocardial infarction (TV-MI) and the ischemia-driven target lesion revascularization.
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: 30days, 3,6,9 months and 1,2,3,4,5 years
Ischemia-driven Target Lesion Revascularization (iTLR)
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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: 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)
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: 30 days, 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 1, 2, 3, 4, 5 years