Axetis Inert Coronary Stent System First In Man Clinical Investigation (AXETIS FIM)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 35
- 试验地点
- 3
- 主要终点
- In-stent Late Lumen Loss (LLL) assessed by off-line QCA
研究概览
简要总结
Prospective, multicenter, single arm study, to assess the feasibility and safety of the Axetis Inert Stent for treatment of patients with de novo coronary artery stenosis in native vessels.
详细描述
Prospective, multicenter, open-label and single arm study, conducted in 3 interventional cardiology centers in The Netherlands. The objective is to assess the feasibility and safety of the Axetis Inert Stent for treatment of patients with de novo coronary artery stenosis in native vessels. In total, 35 patients will be enrolled. All patients will be treated with Axetis Inert Coronary Stent System. All patients will undergo repeat angiography at 6 months follow-up. Quantitative coronary angiography (QCA) assessment will be performed at baseline (pre- and post-procedure) and at 6 months follow-up. All patients will undergo Optical coherence Tomography (OCT) investigation at baseline (post procedure) and at 6 months follow-up. The primary endpoint is in-stent Late Lumen Loss (LLL) at 6 months after stent implantation as assessed by off-line QCA. Clinical follow-up will occur at 6 and 12 months post-stent implantation.
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
- •18 to 85 years
- •Evidence of myocardial ischemia without elevatedTroponin / cardiac biomarkers (e.g.
- •stable or unstable angina, silent ischemia demonstrated by positive territorial functional study). NSTEMI patients are allowed, as long as Troponin is within the normal limits before the start of the procedure.
- •The patient has a planned intervention of up to two de-novo lesions in two different vessels (previously untreated vessels)
- •Lesion must have a visually estimated diameter stenosis of ≥50% and <100%.
- •Lesion length must be ≤ 28 mm
- •RVD must be between 2.4 and 3.8 mm
- •Written informed consent
- •The patient and the patient's physician agree to the follow-up visits including angiographic follow-up and OCT control at 6 months
排除标准
- •Evidence of ongoing acute myocardial infarction in ECG and or elevated cardiac biomarkers prior to procedure.
- •LVEF <30%
- •Platelet count <100,000 cells/mm3 or >400,000 cells/mm3, a WBC of <3,000 cells/mm3, or documented or suspected liver disease (including laboratory evidence of hepatitis)
- •Known renal insufficiency (e.g., eGFR <60 ml/kg/m2 or serum creatinine level of >2.5 mg/dL, or subject on dialysis)
- •History of bleeding diathesis or coagulopathy
- •The patient is a recipient of a heart transplant
- •Known hypersensitivity or contraindication to aspirin, heparin, antiplatelet medication specified for use in the study (clopidogrel, prasugrel, ticagrelor and ticlopidine) or stainless steel
- •Other medical illness (e.g. cancer, stroke with neurological deficiency) or known history of substance abuse (alcohol, cocaine, heroin etc.) as per physician judgment that may cause non-compliance with the protocol or confound the data interpretation or is associated with a limited life expectancy
- •Pregnant or breastfeeding woman or woman in fertile period not taking adequate contraceptives
- •Severe tortuous, calcified or angulated coronary anatomy of the study vessel that in the opinion of the investigator would result in suboptimal imaging or excessive risk of complication from placement of an OCT catheter
- •Target lesion in left main stem.
- •Target lesion involves a side branch > 2.0mm in diameter
- •Aorto-ostial target lesion (within 3 mm of the aorta junction).
- •Total occlusion or TIMI flow 1, prior to wire crossing
- •The target vessel contains visible thrombus
- •Restenotic lesion
- •Target vessel with previously placed stent or with graft
- •Located within an arterial or saphenous vein graft
- •Treatment of more than 1 lesion in one vessel, or treatment of more than two lesions
结局指标
主要结局
In-stent Late Lumen Loss (LLL) assessed by off-line QCA
时间窗: 6 months after stent implantation
次要结局
- maximal neointimal thickness(6 months after intervention)
- Percent procedural success(post intervention (1 hour))
- Number of adverse cardiac events(12 months after intervention)
- Acute Lumen gain(Post intervention (1 hour))
- Acute area gain(Post intervention (1 hour))
- Percent Acute device success(1 day post intervention)
- late lumen loss(6 months after intervention)