NCT03386370Unknown不适用
Indian Registry (The INDigo System in Acute Lower Limb malperfusioN)
Azienda Ospedaliera Universitaria Senese2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2017年9月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Technical success of the thromboaspiration with the Indigo system.
研究概览
简要总结
To evaluate, in a controlled setting, the early safety and effectiveness of the Penumbra/Indigo aspiration thrombectomy Systems (San Francisco, California), and to define optimal technique for the use of these systems in patients with confirmed peripheral acute occlusions.
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
- •Patients will be selected based on the investigator's assessment and evaluation of the underlying disease.
- •The patient's medical condition should be stable, with no underlying medical condition that would prevent them from performing the required testing or from completing the study.
- •Patients should be geographically stable, willing and able to cooperate in this clinical study, and remain available for mid term follow-up. Patients who do not wish to participate in this study can obtain any other standard commercially available device therapy. Refusal to participate in this study will in no way affect their care at the institution.
- •Inclusion Criteria
- •Patient presenting with an acute occlusion of lower limb arteries (thrombosis no longer than 14 days)
- •Patient presenting a score from I to IIb following Rutherford classification for acute limb ischemia
- •Patient is willing to comply with specified follow-up evaluations at the specified times for the duration of the study
- •Patient is >18 years old
- •Patient (or their legal representative) understands the nature of the procedure and provides written informed consent, prior to enrolment in the study
- •Patient is eligible for treatment with the Indigo System (Penumbra)
排除标准
- •Estimated time of intraluminal thrombus > 14 days
- •Patients refusing treatment
- •Patients for whom antiplatelet therapy, anticoagulants or thrombolytic drugs are contraindicated
- •Patients with a history of prior life-threatening contrast medium reaction
- •Life expectancy of less than six months
- •Any patient considered to be hemodynamically unstable at onset of procedure
研究组 & 干预措施
Treatment by "Indigo" mechanical thrombectomy system
Other
Acute or Chronic clot: if chronic (> 14 days) no intervention given via Indigo
干预措施: "Indigo" Mechanical Thrombectomy System (Device)
结局指标
主要结局
Technical success of the thromboaspiration with the Indigo system.
时间窗: At intra-procedural completion angiography
The primary endpoint of the study is the technical success of the thromboaspiration with the Indigo system. Assessment of vessel patency will be recorded using the Thrombolysis in Myocardial Infarction (TIMI) score classifications both before and after use of the device.
次要结局
- Safety Rate at discharge: Serious adverse event.(1 month)
- Clinical success at 1 month follow-up.(1 month)
- Primary Patency(1 month)
研究者
Carlo Setacci, Gianmarco de Donato
University of Siena
Azienda Ospedaliera Universitaria Senese
研究点 (2)
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