NCT01403077已完成不适用
A Safety Assessment of the 480 Biomedical Bioresorbable Scaffold System in the Treatment of de Novo SFA Lesions
480 Biomedical7 个研究点 分布在 4 个国家目标入组 46 人开始时间: 2011年10月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 46
- 试验地点
- 7
- 主要终点
- Major adverse events at 6 months post procedure
研究概览
简要总结
This is an initial evaluation of the 480 Biomedical Bioresorbable Scaffold System for the treatment of subjects with de novo native superficial femoral 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >/= 18 years
- •De novo stenotic lesion(s) in the superficial femoral artery located at least 1cm distal to the femoral bifurcation and > 3 cm above the knee joint
- •Lifestyle-limiting claudication defined as symptomatic subjects with Rutherford Becker Category 2-3
- •Target lesion native reference vessel diameter 4.6 - 6.0 mm by on-line QVA; target lesion native reference vessel diameter less than 5.0 mm only if lesion residual stenosis is ≤ 25%
- •Lesion length: up to a maximum that can be covered by one 100mm scaffold
- •Target lesion > 50% stenosis or total occlusion
- •Undisturbed flow to the foot via at least 2 patent infrapopliteal vessel on the treated side with one vessel free from > 50% stenosis to the ankle joint
- •Patent common and external iliac; TASC A & B lesions may be successfully treated (<30% residual stenosis) at the time of the index procedure
- •The study patient or the study patient's legal representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the Human Research Ethics Committee (HREC) of the respective clinical site
- •The study patient agrees to comply with all required post-procedure follow-up visits
排除标准
- •Previously implanted stent(s) or stent graft(s) in the target lesion
- •Previous endovascular treatment of the target lesion
- •Femoral access in the target limb within 30 days of study procedure
- •Target lesion residual stenosis > 30% after pre-dilatation with nominally sized balloon
- •Severely calcified lesions as determined by a balloon deformity during dilatation with a nominally sized balloon inflated at nominal pressure.
- •Acute embolic complication at the trifurcation following pre-dilatation not resolved by aspiration
- •Target vessel contains acute thrombus
- •Aneurysm in target vessel
- •Critical limb ischemia defined as Rutherford-Becker Category 4-6
- •Intolerance, or allergies which cannot be adequately pre-medicated, to the following: aspirin, clopidogrel or ticlopidine, heparin, any scaffold components, contrast agents
- •Life expectancy of less than 12 months
- •Pregnancy or breast feeding (negative pregnancy test within 7 days required in females of child bearing potential)
- •Non-atherosclerotic lesion (e.g. vasculitis or Berger's disease)
- •Renal insufficiency (serum creatinine level > 220 µmol/L, or subject is on dialysis)
- •Immunocompromised
- •Active systemic infection or lower limb infection of any nature
- •WBC < 3,000 cells/mm3
- •Myocardial infarction within the past 1 month
- •Stroke within 3 months
- •Un-controlled Atrial-Fibrillation
- •Currently participating in an investigational drug or another device study. Note: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials
结局指标
主要结局
Major adverse events at 6 months post procedure
时间窗: 6 Months
次要结局
- Major adverse events at 3, 12 months and 24 months post procedure(3, 12 & 24 Months)
- Walking Impairment Questionnaire(1, 3, 6, 12, 24 Months)
- Ankle-Brachial Index (ABI) at 1, 3, 6, 12, and 24 months post procedure(1, 3, 6, 12, 24 Months)
- Clinically driven TLR at 3, 12 and 24 months post procedure(3,12, 24 Months)
- Patency in the treated vessel at 1, 3, 6, 12 and 24 months post procedure(1, 3, 6, 12, 24 Months)
- Major adverse events at 1 month post procedure(1 Month)
- Change in Rutherford Becker Category at 1, 3, 6,12 and 24 months post procedure(1, 3, 6, 12, 24 Months)
研究者
研究点 (7)
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