Coronary Artery Disease
Conditions
Keywords
NeoVas, Bioresorbable scaffold, Sirolimus, First-in-Man
Brief summary
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.
Detailed description
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.
Interventions
DEVICENeoVas BCS
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.
Sponsors
Lepu Medical Technology (Beijing) Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Age must be between 18 and 75 years, men or unpregnant women * Patient must have evidence of myocardial ischemia (e.g., stable angina, unstable angina) * Total number of target lesion =1 per patient * 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 * Patient must be an acceptable candidate for coronary artery bypass graft. * Patient is able to verbally confirm understanding of risks, benefits and treatment of receiving the NeoVas bioresorbable coronary scaffold and he/she or his/her legally authorized representative provides written informed consent prior to any clinical investigation related procedure, as approved by the appropriate Ethics Committee of the respective clinical site.
Exclusion criteria
* Patients has had a known diagnosis of acute myocardial infarction (AMI) within 30 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, fork and bridge vessel lesions of branch vessels whose diameter ≥2.0mm(branch opening stenosis exceeds 40% or need balloon expansion); 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 6 months after the study procedure; target vessels that has been planted stents over a year. * Severe heart failure(over NYHA III grade ), or left ventricular ejection fraction(LVEF)\< 40%( supersonic inspection or left ventricular radiography ) * Known renal insufficiency (e.g., eGFR \<60 ml/min, 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 can not bear anticoagulation treatment * Patient has a known hypersensitivity or contraindication to aspirin, clopidogrel, 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 which in the investigator's opinion may limit his/her ability to participate in the study * 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, coumadin) * Elective surgery is planned within the first 6 months after the procedure that will require discontinuing either aspirin or clopidogrel * Platelet count \<100,000 cells/mm3 or \>700,000 cells/mm3, a WBC of \<3,000 cells/mm3, or documented or suspected liver disease (including laboratory evidence of hepatitis) * Patient has extensive peripheral vascular disease that precludes safe 6 French sheath insertion
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Target Lesion Failure(TLF) | 30 days | Target lesion failure is a composite endpoint of cardiac death, target vessel related myocardial infarction (TV-MI) and the ischemia-driven target lesion revascularization. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Oriented Composite Endpoint | 30 days | Patients oriented composite endpoint includes all-cause death, all myocardial infarction and any revascularization. |
| Acute Success (Clinical Device and Clinical Procedure) | acute | 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. |
| Scaffold Thrombosis | 30days | 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. |
| Target Lesion Failure | 6 months | Target lesion failure is a composite endpoint of cardiac death, target vessel related myocardial infarction (TV-MI) and the ischemia-driven target lesion revascularization. |
| OCT Endpoint | 6 months | proportion of covered struts, malapposed struts; neointimal hyperplasia (NIH) area, volume; NIH volume obstruction. |
| IVUS Endpoint | 6 months | mean/minimal vessel area, mean/minimal lumen area, mean/minimal stent area |
| MSCT Endpoint | 1 year | mean/minimal vessel area, mean/minimal lumen area, mean/minimal stent area |
| Angiographic Endpoint | 6 months | 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 (%). |
Countries
China
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 31 |
| Total | 31 |
Baseline characteristics
| Characteristic | NeoVas BCS |
|---|---|
| Age, Continuous | 59.1 years STANDARD_DEVIATION 8.7 |
| Angina Categories NSTEMI | 1 participants |
| Angina Categories Stable angina | 7 participants |
| Angina Categories Unstable angina | 23 participants |
| Diabetes Mellitus No | 24 participants |
| Diabetes Mellitus Yes | 7 participants |
| Hypertension No | 15 participants |
| Hypertension Yes | 16 participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 24 Participants |
| Stent diameter | 3.35 millimeter STANDARD_DEVIATION 0.23 |
| Stent length | 19.35 millimeter STANDARD_DEVIATION 3.54 |
| Target vessel location Left anterior descending artery | 17 participants |
| Target vessel location Left circumflex artery | 3 participants |
| Target vessel location Right coronary artery | 11 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 31 |
| serious Total, serious adverse events | 0 / 31 |
Outcome results
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.
Time frame: 30 days
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| NeoVas BCS | Target Lesion Failure(TLF) | Yes | 0 participants |
| NeoVas BCS | Target Lesion Failure(TLF) | No | 31 participants |
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.
Time frame: acute
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| NeoVas BCS | Acute Success (Clinical Device and Clinical Procedure) | Success | 31 participants |
| NeoVas BCS | Acute Success (Clinical Device and Clinical Procedure) | Failure | 0 participants |
Secondary
Angiographic Endpoint
Time frame: 5 years
Secondary
Angiographic Endpoint
Time frame: 2 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 (%).
Time frame: 6 months
Secondary
IVUS Endpoint
Time frame: 2 years
Secondary
IVUS Endpoint
mean/minimal vessel area, mean/minimal lumen area, mean/minimal stent area
Time frame: 6 months
Secondary
IVUS Endpoint
Time frame: 5 years
Secondary
MSCT Endpoint
Time frame: 3 years
Secondary
MSCT Endpoint
mean/minimal vessel area, mean/minimal lumen area, mean/minimal stent area
Time frame: 1 year
Secondary
OCT Endpoint
Time frame: 2 years
Secondary
OCT Endpoint
Time frame: 5 years
Secondary
OCT Endpoint
proportion of covered struts, malapposed struts; neointimal hyperplasia (NIH) area, volume; NIH volume obstruction.
Time frame: 6 months
Secondary
Patient Oriented Composite Endpoint
Patients oriented composite endpoint includes all-cause death, all myocardial infarction and any revascularization.
Time frame: 30 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| NeoVas BCS | Patient Oriented Composite Endpoint | 0 participants |
Secondary
Patient Oriented Composite Endpoint
Time frame: 2 years
Secondary
Patient Oriented Composite Endpoint
Time frame: 3 years
Secondary
Patient Oriented Composite Endpoint
Time frame: 5 years
Secondary
Patient Oriented Composite Endpoint
Time frame: 4 years
Secondary
Patient Oriented Composite Endpoint
Time frame: 1 year
Secondary
Patient Oriented Composite Endpoint
Patients oriented composite endpoint includes all-cause death, all myocardial infarction and any revascularization.
Time frame: 6 months
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.
Time frame: 30days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| NeoVas BCS | Scaffold Thrombosis | 0 participants |
Secondary
Scaffold Thrombosis
Time frame: 6 months
Secondary
Scaffold Thrombosis
Time frame: 1 year
Secondary
Scaffold Thrombosis
Time frame: 2 years
Secondary
Scaffold Thrombosis
Time frame: 3 years
Secondary
Scaffold Thrombosis
Time frame: 4 years
Secondary
Scaffold Thrombosis
Time frame: 5 years
Secondary
Target Lesion Failure
Time frame: 5 years
Secondary
Target Lesion Failure
Time frame: 4 years
Secondary
Target Lesion Failure
Time frame: 3 years
Secondary
Target Lesion Failure
Time frame: 2 years
Secondary
Target Lesion Failure
Time frame: 1 year
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.
Time frame: 6 months