NeoVas Bioresorbable Coronary Scaffold Randomized Controlled Trial
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|ClinicalTrials.gov Identifier: NCT02305485|
Recruitment Status : Active, not recruiting
First Posted : December 2, 2014
Last Update Posted : December 8, 2016
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Disease||Device: NeoVas BCS Device: XIENCE PRIME EECSS||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||560 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Clinical Evaluation of a Bioresorbable Sirolimus-eluting Coronary Scaffold in the Treatment of Patients With Denovo Coronary Artery Lesion (NeoVas): Randomized Controlled Trial|
|Study Start Date :||November 2014|
|Actual Primary Completion Date :||December 2016|
|Estimated Study Completion Date :||June 2020|
The NeoVas sirolimus-eluting bioresorbable coronary scaffold system is a PLLA- based polymer scaffold and contains the antiproliferative drug sirolimus.
Intervention: Device: NeoVas BCS
Device: NeoVas BCS
Subjects receiving NeoVas BCS
Other Name: NeoVas Bioresorbable Coronary Scaffold
Active Comparator: XIENCE PRIME
XIENCE PRIME Everolimus Eluting Coronary Stent System is a balloon expandable metallic platform stent manufactured from a flexible cobalt chromium alloy with a multicellular design and coated with a thin nonadhesive, durable, biocompatible acrylic, and fluorinated everolimus-releasing copolymer. Intervention: Device: XIENCE PRIME EECSS
Device: XIENCE PRIME EECSS
Subjects receiving XIENCE PRIME EECSS
Other Name: XIENCE PRIME Everolimus Eluting Coronary Stent System
- In-segment late lumen loss (LLL) [ Time Frame: 1 year ]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.
- Major secondary endpoint: Percentage of patients who experienced angina within 1 year [ Time Frame: From 7 days post-procedure to 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).
- Device Success [ Time Frame: intraoperative ]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.
- Procedural Success [ Time Frame: At time of procedure up to 7 days in hospital ]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.
- Target lesion failure(TLF) [ Time Frame: 30days, 3,6,9 months and 1,2,3,4,5 years ]Target lesion failure is a composite endpoint of cardiac death, target vessel related myocardial infarction (TV-MI) and the ischemia-driven target lesion revascularization.
- 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) [ Time Frame: 30 days, 3,6,9 months and 1, 2, 3, 4, 5 years ]percutaneous coronary intervention (PCI) coronary artery bypass graft (CABG)
- Scaffold thrombosis [ Time Frame: 30days, 3,6,9 months and 1, 2, 3, 4, 5 years ]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.
- Percentage of patients who experienced angina [ Time Frame: 30days, 3,6,9 months and 2, 3, 4, 5 years ]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).
- Patient oriented composite endpoint [ Time Frame: 30 days, 3,6,9 months and 1, 2, 3, 4, 5 years ]Patients oriented composite endpoint includes all-cause death, all myocardial infarction and any revascularization.
- Primary Endpoint for the Subgroup Study: Changes of the average lumen diameter before and after the usage of nitroglycerin [ Time Frame: 3 years ]
- Secondary Endpoint for the Subgroup Study: Angiographic Endpoint(after the usage of nitroglycerin) [ Time Frame: Index procedure, 1 and 3 years ]In-segment, in-scaffold, 5mm proximal and 5mm distal Late and very late lumen loss (mm); In-segment, in-scaffold, 5mm proximal and 5mm distal Minimal lumen diameter(mm); In-segment, in-scaffold, 5mm proximal and 5mm distal Diameter stenosis (%);In-segment, in-scaffold, 5mm proximal and 5mm distal Angiographic Binary Restenosis (%).
- Secondary Endpoint for the Subgroup Study: OCT Endpoint (after the usage of nitroglycerin) [ Time Frame: Index procedure, 1 and 3 years ]Mean/minimal lumen area, mean/minimal stent area, average neointimal hyperplasia (NIH) area, proportion of covered struts, proportion of malapposed struts.
- Secondary Endpoint for the Subgroup Study: FFR Endpoint (after the usage of nitroglycerin): Late and very late FFR loss/changes [ Time Frame: 1 and 3 years ]
- Secondary Endpoint for Subgroup Study: FFR Endpoint (after the usage of nitroglycerin): Target lesion FFR [ Time Frame: post-procedure, 1 and 3 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02305485
Show 27 Study Locations
|Study Chair:||Yaling Han, MD||The general hospital of Shenyang military region|
|Principal Investigator:||Guosheng Fu||Sir Run Run Shaw Hospital|
|Principal Investigator:||Bo Xu||Beijing Fuwai hospital, National center for cardiovascular diseases China|