The NeoVas First-in-Man study is a prospective, two centers, single arm trial, which will enroll a total of 30 patients. The hypothesis of this study is to evaluate clinical feasibility, safety, and efficacy of NeoVas sirolimus-eluting bioresorbable coronary scaffold in the treatment of patients with de novo coronary lesion.
The primary endpoint is a composite endpoint of cardiac death, target vessel related myocardial infarction, and ischemia driven target lesion revascularization (TLF) at 1 month follow up. At 6 months, 1, 2, 3, 4 and 5 years follow-up, clinical endpoints include TLF (its individual components), Patient-oriented cardiac event (all cause death, all MI, and all revascularization) target vessel revascularization, scaffold thrombosis.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
31
The NeoVas First-in-Man study is a prospective, two centers, single arm trial, which will enroll a total of 30 patients. The hypothesis of this study is to evaluate clinical feasibility, safety, and efficacy of NeoVas sirolimus-eluting bioresorbable coronary scaffold in the treatment of patients with de novo coronary lesion. The primary endpoint is a composite endpoint of cardiac death, target vessel related myocardial infarction, and ischemia driven target lesion revascularization (TLF) at 1 month follow up. At 6 months, 1, 2, 3, 4 and 5 years follow-up, clinical endpoints include TLF (its individual components), Patient-oriented cardiac event (all cause death, all MI, and all revascularization) target vessel revascularization, scaffold thrombosis.
The General Hospital of Shenyang Military Region
Shenyang, Liaoning, China
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
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.
Time frame: 30 days
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: 6 months
Target Lesion Failure
Time frame: 1 year
Target Lesion Failure
Time frame: 2 years
Target Lesion Failure
Time frame: 3 years
Target Lesion Failure
Time frame: 4 years
Target Lesion Failure
Time frame: 5 years
Patient Oriented Composite Endpoint
Patients oriented composite endpoint includes all-cause death, all myocardial infarction and any revascularization.
Time frame: 30 days
Patient Oriented Composite Endpoint
Patients oriented composite endpoint includes all-cause death, all myocardial infarction and any revascularization.
Time frame: 6 months
Patient Oriented Composite Endpoint
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Time frame: 1 year
Patient Oriented Composite Endpoint
Time frame: 2 years
Patient Oriented Composite Endpoint
Time frame: 3 years
Patient Oriented Composite Endpoint
Time frame: 4 years
Patient Oriented Composite Endpoint
Time frame: 5 years
Acute Success (Clinical Device and Clinical Procedure)
Successful delivery and deployment of the Clinical Investigation scaffold at the intended target lesion and successful withdrawal of the scaffold delivery system with attainment of final residual stenosis of less than 50% of the target lesion by QCA (by visual estimation if QCA unavailable). Successful delivery and deployment of the Clinical Investigation scaffold at the intended target lesion and successful withdrawal of the scaffold delivery system with attainment of final residual stenosis of less than 50% of the target lesion by QCA (by visual estimation if QCA unavailable) and/or using any adjunctive device without the occurrence of ischemia driven major adverse cardiac event (MACE) during the hospital stay with a maximum of first seven days post index procedure. In dual lesion setting both lesions must meet clinical procedure success.
Time frame: acute
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 targetlesion within 30 days.
Time frame: 30days
Scaffold Thrombosis
Time frame: 6 months
Scaffold Thrombosis
Time frame: 1 year
Scaffold Thrombosis
Time frame: 2 years
Scaffold Thrombosis
Time frame: 3 years
Scaffold Thrombosis
Time frame: 4 years
Scaffold Thrombosis
Time frame: 5 years
Angiographic Endpoint
In-segment In-scaffold, proximal and distal Late lumen loss (mm); In-segment In-scaffold, proximal and distal Minimal lumen diameter(mm); In-segment In-scaffold, proximal and distal Diameter stenosis (%) Angiographic Binary Restenosis (%).
Time frame: 6 months
Angiographic Endpoint
Time frame: 2 years
Angiographic Endpoint
Time frame: 5 years
OCT Endpoint
proportion of covered struts, malapposed struts; neointimal hyperplasia (NIH) area, volume; NIH volume obstruction.
Time frame: 6 months
OCT Endpoint
Time frame: 2 years
OCT Endpoint
Time frame: 5 years
IVUS Endpoint
mean/minimal vessel area, mean/minimal lumen area, mean/minimal stent area
Time frame: 6 months
IVUS Endpoint
Time frame: 2 years
IVUS Endpoint
Time frame: 5 years
MSCT Endpoint
mean/minimal vessel area, mean/minimal lumen area, mean/minimal stent area
Time frame: 1 year
MSCT Endpoint
Time frame: 3 years