跳至主要内容
临床试验/NCT03295539
NCT03295539Unknown不适用

MulticentRe pOst-market exPeriencE With the INdigo Thrombectomy System for the Treatment of Acute Lower Limb Ischaemia : (Re-Open Registry)

Lancashire Care NHS Foundation Trust2 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2017年11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
400
试验地点
2
主要终点
Technical success using the Indigo system.

研究概览

简要总结

International Multi-Centre registry recording comprehensive data on the use of 'Indigo' Mechanical thrombectomy system by Penumbra Inc for the removal of acute clot causing acute or critical limb ischaemia.

详细描述

A detailed registry has been designed and approved to be used world wide in vascular and trauma centres, already providing endovascular service for the management of critical limb ischaemia (CLI).

Recent campaigns have shown little is done to improve flow to the lower limbs (legs) of patients to avoid amputation rates. During this time many devises have been used and available on the market. The 'Indigo' system by Penumbra was originally designed from the acute stroke system "ACE". Similar principles were applied in designing the 'Indigo' system. This is currently being used in many centres to manage acute clot causing lower limb ischaemia, however no official registry or international clinical trial has been done to show its significance in managing this disease.

The investigator groups, have created this to come up with enough data to evaluate the Indigo system in the management of (ALI) and offer tips and tricks to other clinicians. The aim is for a single arm, multicenter, retrospective analysis of patients in whom (ALI) was performed with the Penumbra/Indigo System (study device), and gather greater data and information than the PRISM trial in 2013-2014 which obtained only 79 patients.

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

性别
All
接受健康志愿者

入选标准

  • Acute lower limb Ischaemia with acute soft clot.

排除标准

  • Calcified plaques/ chronic disease causing critical limb Ischaemia

研究组 & 干预措施

Acute or Chronic clot

Other

If chronic clot, no intervention given via Indigo

干预措施: 'Indigo' Mechanical thrombectomy system (Device)

结局指标

主要结局

Technical success using the Indigo system.

时间窗: Time to event anaylsis. Primary patency results are immediate after the case on the final angiogram images.

Intraoperative technical success defined as the restoration of antegrade blood flow with complete or near complete (95% by volume) removal of the thrombus or embolus (70% threshold). This is assessed using imaging modalities (USS/Doppler/Fluroscopy) and clinical assessment of the affected limb. See for this definition the enclosed citation. In conclusion, the primary outcome measure will be improvement in blood flow across a lesion assessed by the improvement in Thrombolysis in Myocardial Infarction (TIMI) score that was adapted to peripheral arteries. Concomitant balloon angioplasty or stent placement in addition to VAT was considered a complementary treatment. Additional thrombectomy treatments, such as thrombolysis and mechanical thrombectomy, were considered technical failures.Target lesions were grouped anatomically into above-the-knee(ATK) or below-the-knee(BTK) lesions.

次要结局

未报告次要终点

研究者

发起方
Lancashire Care NHS Foundation Trust
申办方类型
Network
责任方
Principal Investigator
主要研究者

Bella Huasen

Endovascular Interventional Consultant

Lancashire Care NHS Foundation Trust

研究点 (2)

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