NCT01168830已完成不适用
BIOTRONIKS-Safety and Clinical Performance Of the First Drug-Eluting Generation Absorbable Metal Stent In Patients With de Novo Lesions in NatiVE Coronary Arteries (BIOSOLVE - I)
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Biotronik AG
- 入组人数
- 46
- 试验地点
- 6
- 主要终点
- Target Lesion Failure
研究概览
简要总结
First in Man Trial with the drug eluting absorbable metal scaffold. To assess safety
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is > 18 years and < 80 years of age
- •Written patient informed consent available prior to PCI
- •Patients with stable or unstable angina pectoris or documented silent ischemia
- •Patient eligible for PCI
- •Patient acceptable candidate for coronary artery bypass surgery
排除标准
- •Left ventricular ejection fraction of < 30%
- •Presence of a visible thrombus in the target vessel visualized by angiography
- •Lesion and/or way to lesion extremely calcified (e.g. IVUS catheter can not reach/cross the lesion)
- •Patients with three-vessel where all three vessels require treatment
- •Patients with previous CABG in the target vessel(s)
- •Patients with known coronary artery spasm
- •Myocardial infarction (STEMI/NSTEMI) within 4 weeks of the intended treatment. Determination of CKMB and/or troponin T or I is required.
- •Patients with planned major surgery within 12 months after coronary intervention
- •Patients with risk of either acetylsalicylic acid, clopidogrel or Prasugrel cessation
- •Patients under current Phenprocoumon or Cumarine therapy
- •Impaired renal function (serum creatinine > 2.0mg/dl or 177micromol/l, determined within 72 hours prior to intervention)
- •Additional coronary lesions (restenotic or de novo) in the same vessel which requires treatment
- •Totally occluded coronary artery (TIMI flow 0)
- •Lesions located within arterial or venous graft
- •Ostial lesions
- •Previous and/or planned brachytherapy of target vessel
- •Target lesion located in left main coronary artery
- •Stroke or TIA < 6 months prior to procedure
- •Patient with signs of a cardiogenic shock
- •Surgeries of any kind within 30 days prior to screening
- •Patient with bleeding diathesis in whom anticoagulation or antiplatelet medication is contraindicated
- •Pregnant and/or breast-feeding females or females who intend to become pregnant
- •Patient currently enrolled in other investigational device or drug trial
- •Patient with expected incompliance to medical (antiplatelet, anticoagulation) therapy
研究组 & 干预措施
Investigational device
Experimental
干预措施: AMS-3.0 (Device)
结局指标
主要结局
Target Lesion Failure
时间窗: 6 and 12 months
次要结局
未报告次要终点
研究者
研究点 (6)
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