NeoVas Bioresorbable Coronary Scaffold Registry Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Clinical Evaluation of a Bioresorbable Sirolimus-eluting Coronary Scaffold in the Treatment of Patients With de Novo Coronary Artery Lesion (NeoVas): a Single Arm Registry Study

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: NeoVas BCS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age must be 18-75 years, men or unpregnant women. Patient must have evidence of myocardial ischemia, suitable for elective PCI. Subjects with stable angina or silent ischemia and <70% diameter stenosis must have objective sign of ischemia as determined by one of the following, echocardiogram, nuclear scan, ambulatory ECG or stress ECG. In the absence of noninvasive ischemia, fractional flow reserve(FFR) must be done and indicative of ischemia. Patients with one or two de novo lesions located in different epicardial vessels. Target lesion must be≤20mm in length(visual estimation)and 2.75 to 3.75 mm in diameter(Online QCA). Target lesion is with a visually estimated stenosis of ≥70%(or≥50% and evidence of myocardial ischemia) with a TIMI flow of ≥1. The target lesion can be covered by one scaffold(except the rescue scaffold). Patient must be an acceptable candidate for coronary artery bypass graft. Patient or a legally authorized representative must provide written Informed Consent prior to any study related procedure. Exclusion Criteria: Patients has had a known diagnosis of acute myocardial infarction(AMI) within 7 days preceding the procedure; CK and CK-MB have not returned within normal limits at the time of procedure. Chronic total occlusion lesions (TIMI 0 grade blood flow prior to implantation), left trunk vessel lesion, ostial lesion, multi-branch lesions needing treated, bifurcation lesion (diameter ≥2.0mm, branch opening stenosis exceeds 50% or need balloon expansion) and bridge vessel lesions; there is thrombus visible in the target blood vessels. Severe calcified lesions and twisted lesions which cannot be pre-expanded, and lesions unsuitable for delivering and expanding stents. In-stent restenosis lesion. Patient has undergone previous stenting anywhere within the target vessel(s) within the previous 12 months, or will require stenting within the target vessel(s) within 1 year after the study procedure; target vessels that has been implanted with stents. Severe heart failure(over NYHA III grade ), or left ventricular ejection fraction(LVEF)<40%( supersonic inspection or left ventricular radiography ). Known renal insufficiency(eGFR<60 ml/min, serum creatinine>2.5mg/dL, or subject on dialysis). Patients with hemorrhage tendency, an active digestive ulcer history, a cerebral hemorrhage or subarachnoid hemorrhage history, or cerebral apoplexy within half a year, and these patients who contraindicate against platelet inhibitors and anticoagulant therefore cannot bear anticoagulation treatment. Patient has a known hypersensitivity or contraindication to aspirin, clopidogrel, ticagrelor or prasugrel, heparin, contrast agent, polylactic acid or sirolimus that cannot be adequately pre-medicated. Life expectancy < 12 months. Patient is participating in another device or drug study that has not reached the primary endpoint of the study. Patient's inability to fully cooperate with the study protocol. Patient has a heart transplant. Patient has current unstable arrhythmias, such as high risk ventricular premature beat and ventricular tachycardia. Patient is receiving or scheduled to receive chemotherapy for malignancy within 30 days prior to or after the procedure. Patient is receiving immunosuppression therapy and has known immunosuppressive or autoimmune disease. Patient is receiving or scheduled to receive chronic anticoagulation therapy (e.g., heparin, warfarin). Elective surgery is planned within the first 6 months after the procedure that will require discontinuing either aspirin, clopidogrel, ticagrelor or prasugrel. Platelet count<100,000 cells/mm3 or>700,000 cells/mm3, a WBC of<3,000 cells/mm3, or documented or suspected liver disease. Patient has extensive peripheral vascular disease that precludes safe 6 French sheath insertion.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NeoVas BCS<br>The NeoVas sirolimus-eluting bioresorbable coronary scaffold system is a PLLA-based polymer scaffold and contains the antiproliferative drug sirolimus. | Device: NeoVas BCS<br>* Subjects receiving NeoVas BCS<br>* Other names: NeoVas Bioresorbable Coronary Scaffold;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 30days, 3,6,9 months and 1,2,3,4,5 years | 
| Ischemia-driven Target Lesion Revascularization (iTLR) |  | 30 days, 3,6,9 months and 1, 2, 3, 4, 5 years | 
| Ischemia-driven Target Vessel Revascularization (iTVR) |  | 30 days, 3,6,9 months and 1, 2, 3, 4, 5 years | 
| All coronary revascularization (PCI and CABG) |  | 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. | 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). | 30days, 3,6,9 months and 1, 2, 3, 4, 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NeoVas, Bioresorbable Coronary Scaffold, Sirolimus, Registry Trial