A Clinical Evaluation of the Bard® Luminexx™ Iliac Stent and Delivery System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 134
- 主要终点
- Rate of Major Adverse Clinical Events (MACE)
研究概览
简要总结
To determine the safety and effectiveness of the LUMINEXX stent for the proposed indication of treatment of common and/or external iliac artery occlusive disease
详细描述
The study is designed to collect safety and efficacy data on the Bard Luminexx Iliac Stent in a broad patient population having indications for iliac stenting. Effectiveness in this study will be demonstrated by the prevention of Major Adverse Clinical Events (MACE). The composite primary endpoint of this clinical trial is freedom from peri-procedural death and freedom from stented segment revascularization or restenosis (>50%) at nine months.
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
- •Patient or legal guardian understands procedure and provides written informed consent prior to study participation.
- •Patient must be able and willing to comply with all study procedures including scheduled follow-up visits and diagnostic tests.
- •Lesion(s) distinctly localized in the common and/or external iliac arteries.
- •Reference lumen diameter (RLD) 6 mm and 9 mm.
- •Stenosis 30% and symptomatic ischemic disease (Category 1-6 Chronic Limb Ischemia or Threatened or Irreversible Acute Limb Ischemia).
排除标准
- •Patients diagnosed with preoperative coagulation disorder or with contraindications to antiplatelet or anticoagulant therapy.
- •Patients who are pregnant or planning to become pregnant during the clinical investigation.
- •Patients with a life expectancy < 3 years.
- •Patients currently or scheduled to be enrolled in another investigation that conflicts with follow-up testing or may confound the study data.
- •Patients with absolute contraindication to x-ray contrast media or medications normally administered during an interventional procedure.
- •Patients with severe tortuosity or angulation of a vessel that may prevent access in the opinion of the investigator.
- •The presence of soft, thrombotic or embolic material within or adjacent to the lesion(s) being treated with the study device, in the opinion of the investigator.
结局指标
主要结局
Rate of Major Adverse Clinical Events (MACE)
时间窗: 9-months
Major Adverse Clinical Events defined as peri-procedural death (death during the procedure or prior to hospital discharge), target lesion revascularization (TLR), or stented segment restenosis (\> 50%) at nine months postprocedure.
次要结局
未报告次要终点