NCT02195414Unknown1 期
Clinical Evaluation of a Bioresorbable Sirolimus-eluting Coronary Scaffold in the Treatment of Patients With de Novo Coronary Artery Lesion (NeoVas): a First-in-Man Study
适应症
试验速览
- 阶段
- 1 期
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Target Lesion Failure(TLF)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Target Lesion Failure(TLF)
时间窗: 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.
次要结局
- Target Lesion Failure(5 years)
- Acute Success (Clinical Device and Clinical Procedure)(acute)
- Scaffold Thrombosis(5 years)
- OCT Endpoint(5 years)
- MSCT Endpoint(3 years)
- IVUS Endpoint(5 years)
- Patient Oriented Composite Endpoint(5 years)
- Angiographic Endpoint(5 years)
研究者
研究点 (2)
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