NCT03263858已完成不适用
Vascular Implant Safety and Efficacy Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 5
- 主要终点
- Strut coverage cohort 1
研究概览
简要总结
Assessment of the safety and clinical performance of a coronary stent system in de novo coronary artery lesions
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is > 18 years and < 85 years old
- •Written subject informed consent
- •Subjects with stable or unstable angina pectoris or documented silent ischemia or hemodynamically stable NSTEMI patients
- •Subject is eligible for percutaneous coronary intervention (PCI)
- •Subject is acceptable candidate for coronary artery bypass surgery
- •Subject is eligible for Dual Anti Platelet Therapy (DAPT)
- •Subjects with a maximum of two single discrete de novo lesions in two separate native coronary arteries that can be treated with the study stent during the index procedure
- •Reference vessel diameter of 3.0 mm to 3.8 mm by visual estimation.
- •Target lesion length up to 22 mm by visual estimation.
- •Target lesion with ≥ 50% and < 100% stenosis by visual estimation
排除标准
- •Left main coronary artery disease
- •Three-vessel coronary artery disease at the time of index procedure
- •Angiographic evidence of thrombus in target vessel
- •Chronic total occlusion
- •Heavily calcified or extremely tortuous lesions that would prevent complete inflation of a pre-dilatation balloon
- •Bifurcation lesion requiring side branch intervention, if side branches > 2mm in diameter are involved
- •Ostial lesions (within 5 mm of vessel origin)
- •In-stent restenosis
- •Lesions with prior treatment with a drug coated balloon (DCB)
- •Target lesion is located in or supplied by an arterial or venous bypass graft
- •Target lesion requires treatment with. rotational atherectomy
- •Proximal or distal to the target lesion located stenosis that might require future revascularization or impede run off detected during diagnostic angiography
- •Previous treatment of target vessel within 9 months of index-procedure
- •Patients with cardiogenic shock
- •Documented left ventricular ejection fraction (LVEF) ≤ 30%
- •Impaired renal function (serum creatinine > 2.5 mg/dl or 221 mmol/l, determined within 72 hours prior to intervention)
- •Hemodynamically unstable NSTEMI or STEMI within 72 hours prior to index procedure
- •Cerebrovascular event (within 3 months of index procedure)
- •Subject is receiving oral or intravenous immuno-suppressive therapy (inhaled steroids are allowed) or has known life-limiting immunosuppressive or autoimmune disease (e.g. human immunodeficiency virus, systemic lupus erythematosus, but not diabetes mellitus)
- •Known allergies to: Acetylsalicylic Acid (ASA), heparin, contrast medium, sirolimus, or similar drugs, exipients or the stent material
- •Triple anticoagulation therapy
- •Life expectancy less than 1 year
- •Pregnant or breast-feeding females or females who intend to become pregnant during the time of the study
- •Inability to understand or read the informed consent form
- •Subject is currently participating in another study with an investigational device or an investigational drug and has not reached the primary endpoint yet
- •In the investigators opinion subjects will not be able to comply with the follow-up requirements
结局指标
主要结局
Strut coverage cohort 1
时间窗: 1 month
Strut coverage will be assessed by OCT analysis
In stent late lumen loss cohort 2
时间窗: 9 months
Late lumen loss with will be assessed by central QCA assessment
次要结局
未报告次要终点
研究者
研究点 (5)
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