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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NeoVas BCS | Experimental | The NeoVas sirolimus-eluting bioresorbable coronary scaffold system is a PLLA-based polymer scaffold and contains the antiproliferative drug sirolimus. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NeoVas BCS | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 30 days |
| 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. | 6 months |
| Target Lesion Failure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yaling Han, MD | The general hospital of Shenyang military region | Study Chair |
| Guosheng Fu | Sir Run Run Shaw Hospital | Principal Investigator |
| Bo Xu | Beijing Fuwai hospital, National center for cardiovascular diseases China | Principal Investigator |
| Yao-Jun Zhang, PhD | Nanjing First Hospital, Nanjing Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The General Hospital of Shenyang Military Region | Shenyang | Liaoning | 110015 | China | ||
| Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University |
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Subjects enrolled into this trial were comprised of male and female subjects from the general interventional cardiology population. The study commenced on June 19, 2014 with the first subject enrolled on this date. The last subject was enrolled September 3, 2014.
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| ID | Title | Description |
|---|---|---|
| FG000 | NeoVas BCS | Patients received the NeoVas sirolimus-eluting bioresorbable coronary scaffold system, which is a PLLA-based polymer scaffold and contains the antiproliferative drug sirolimus. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | NeoVas BCS | Patients received the NeoVas sirolimus-eluting bioresorbable coronary scaffold system, which is a PLLA-based polymer scaffold and contains the antiproliferative drug sirolimus. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age must be between 18 and 75 years. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Number | participants | 30 days |
|
|
30 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | NeoVas BCS | Patients received the NeoVas sirolimus-eluting bioresorbable coronary scaffold system, which is a PLLA-based polymer scaffold and contains the antiproliferative drug sirolimus. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Yaling Han, Study Chair of Clinical Trials | The General Hospital of Shenyang Military Region | +86-024-28856123 | hanyaling@263.net |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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|
|
| 1 year |
| Target Lesion Failure | 2 years |
| Target Lesion Failure | 3 years |
| Target Lesion Failure | 4 years |
| Target Lesion Failure | 5 years |
| Patient Oriented Composite Endpoint | Patients oriented composite endpoint includes all-cause death, all myocardial infarction and any revascularization. | 30 days |
| Patient Oriented Composite Endpoint | Patients oriented composite endpoint includes all-cause death, all myocardial infarction and any revascularization. | 6 months |
| Patient Oriented Composite Endpoint | 1 year |
| Patient Oriented Composite Endpoint | 2 years |
| Patient Oriented Composite Endpoint | 3 years |
| Patient Oriented Composite Endpoint | 4 years |
| Patient Oriented Composite Endpoint | 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. | 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. | 30days |
| Scaffold Thrombosis | 6 months |
| Scaffold Thrombosis | 1 year |
| Scaffold Thrombosis | 2 years |
| Scaffold Thrombosis | 3 years |
| Scaffold Thrombosis | 4 years |
| Scaffold Thrombosis | 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 (%). | 6 months |
| Angiographic Endpoint | 2 years |
| Angiographic Endpoint | 5 years |
| OCT Endpoint | proportion of covered struts, malapposed struts; neointimal hyperplasia (NIH) area, volume; NIH volume obstruction. | 6 months |
| OCT Endpoint | 2 years |
| OCT Endpoint | 5 years |
| IVUS Endpoint | mean/minimal vessel area, mean/minimal lumen area, mean/minimal stent area | 6 months |
| IVUS Endpoint | 2 years |
| IVUS Endpoint | 5 years |
| MSCT Endpoint | mean/minimal vessel area, mean/minimal lumen area, mean/minimal stent area | 1 year |
| MSCT Endpoint | 3 years |
| Hangzhou |
| Zhejiang |
| 310016 |
| China |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Diabetes Mellitus | Number | participants |
|
| Hypertension | Number | participants |
|
| Angina Categories | Number | participants |
|
| Target vessel location | Number | participants |
|
| Stent diameter | Mean | Standard Deviation | millimeter |
|
| Stent length | Mean | Standard Deviation | millimeter |
|
|
| Secondary | 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. | Not Posted | Apr 2016 | 6 months |
| Secondary | Target Lesion Failure | Not Posted | Oct 2016 | 1 year |
| Secondary | Target Lesion Failure | Not Posted | Oct 2017 | 2 years |
| Secondary | Target Lesion Failure | Not Posted | Oct 2018 | 3 years |
| Secondary | Target Lesion Failure | Not Posted | Oct 2019 | 4 years |
| Secondary | Target Lesion Failure | Not Posted | Oct 2020 | 5 years |
| Secondary | Patient Oriented Composite Endpoint | Patients oriented composite endpoint includes all-cause death, all myocardial infarction and any revascularization. | Posted | Number | participants | 30 days |
|
|
|
| Secondary | Patient Oriented Composite Endpoint | Patients oriented composite endpoint includes all-cause death, all myocardial infarction and any revascularization. | Not Posted | Apr 2016 | 6 months |
| Secondary | Patient Oriented Composite Endpoint | Not Posted | Oct 2016 | 1 year |
| Secondary | Patient Oriented Composite Endpoint | Not Posted | Oct 2016 | 2 years |
| Secondary | Patient Oriented Composite Endpoint | Not Posted | Oct 2017 | 3 years |
| Secondary | Patient Oriented Composite Endpoint | Not Posted | Oct 2018 | 4 years |
| Secondary | Patient Oriented Composite Endpoint | Not Posted | Oct 2019 | 5 years |
| Secondary | 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. | Posted | Number | participants | acute |
|
|
|
| Secondary | 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. | Posted | Number | participants | 30days |
|
|
|
| Secondary | Scaffold Thrombosis | Not Posted | Apr 2016 | 6 months |
| Secondary | Scaffold Thrombosis | Not Posted | Oct 2016 | 1 year |
| Secondary | Scaffold Thrombosis | Not Posted | Oct 2017 | 2 years |
| Secondary | Scaffold Thrombosis | Not Posted | Oct 2018 | 3 years |
| Secondary | Scaffold Thrombosis | Not Posted | Oct 2019 | 4 years |
| Secondary | Scaffold Thrombosis | Not Posted | Oct 2020 | 5 years |
| Secondary | 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 (%). | Not Posted | Apr 2016 | 6 months |
| Secondary | Angiographic Endpoint | Not Posted | Oct 2016 | 2 years |
| Secondary | Angiographic Endpoint | Not Posted | Oct 2020 | 5 years |
| Secondary | OCT Endpoint | proportion of covered struts, malapposed struts; neointimal hyperplasia (NIH) area, volume; NIH volume obstruction. | Not Posted | Apr 2016 | 6 months |
| Secondary | OCT Endpoint | Not Posted | Oct 2017 | 2 years |
| Secondary | OCT Endpoint | Not Posted | Oct 2020 | 5 years |
| Secondary | IVUS Endpoint | mean/minimal vessel area, mean/minimal lumen area, mean/minimal stent area | Not Posted | Apr 2016 | 6 months |
| Secondary | IVUS Endpoint | Not Posted | Oct 2017 | 2 years |
| Secondary | IVUS Endpoint | Not Posted | Oct 2020 | 5 years |
| Secondary | MSCT Endpoint | mean/minimal vessel area, mean/minimal lumen area, mean/minimal stent area | Not Posted | Oct 2016 | 1 year |
| Secondary | MSCT Endpoint | Not Posted | Oct 2018 | 3 years |
| 0 |
| 31 |
| 0 |
| 31 |
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| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |