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临床试验/NCT02523261
NCT02523261已完成不适用

Interest of Direct Aspiration First Pass Technique (ADAPT) for Thrombectomy Revascularisation of Large Vessel Occlusion in Acute Ischaemic Stroke

Fondation Ophtalmologique Adolphe de Rothschild8 个研究点 分布在 1 个国家目标入组 381 人开始时间: 2015年10月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
381
试验地点
8
主要终点
Complete recanalization percentage

研究概览

简要总结

Mechanical thrombectomy (TM) is now validated through 4 randomized controlled trials of high scientific level as the reference treatment of cerebral infarction associated with proximal cerebral occlusion (MR CLEAN, ESCAPE 2014, 2015). These studies have shown for the first time a major decrease (-35%) of disability related to severe cerebral infarction and reduction in mortality. These studies only used thrombectomy devices called stent retriever for obtaining recanalization rates ranging from 58-72% for the 2 largest studies (MR CLEAN, ESCAPE 2014, 2015). This criterion "recanalization" is important because it largely determines the functional prognosis of patients with severe cerebral infarction (Khatri, 2014).

These results are exciting but we can do even better. Indeed, already new thrombectomy devices are available with a special interest for ADAPT (A Direct Aspiration First Pass Technic). This distal suction system, with a high level of endovascular navigability, provides high recanalization rates (> 90%), low morbidity, with a synergistic effect with stent retriever (Turk A, Kowoll 2014 and 2015). To date, these technic (ADAPT) has never been assessed in a randomized controlled trial.

We have previously conducted a comparative observational study between two recanalization strategies by thrombectomy using first-line ADAPT or the most widely used stent retriever. The interventional neuroradiologist could, in case of recanalization failure with the Solitaire system, used another thrombectomy material left to the operator's choice. 244 consecutive patients on two centers (Rothschild Foundation, and Foch Hospital, France) admitted for a cerebral infarction associated with proximal occlusion were included. This is so far the largest series of patients with ADAPT system. The complete recanalization rate was 84% with ADAPT versus 68% with stent retriever (P = 0.006). Unpublished data, Oral presentation at the European Stroke Organization, April 2015). Our research aims to show that a first line strategy of recanalization by thrombectomy using a distal suction system (ADAPT) is superior that the use of a stent retriever.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
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

入选标准

  • Age > 18 years with no upper age limit.
  • Cerebral infarction in the anterior circulation
  • Occlusion of the anterior circulation proven by CT angiography or MR angiography
  • With or without previous Intravenous thrombolysis
  • Start of thrombectomy procedure within 6 hours of symptoms onset.
  • Patient expresses verbally his non-opposition to be enrolled in the study ; in case patient cannot communicate, verbal non-opposition is obtained from his close / trusted person

排除标准

  • Absence of indication for thrombectomy
  • Cons-indication for thrombectomy
  • Presence of cerebral infarction of the posterior circulation
  • Occlusion of the cervical carotid artery
  • Allergy to x-ray contrast products
  • Patient was bedridden or using a wheelchair most of the day (pre-event modified Rankin Scale score > 3) prior to stroke
  • Pregnancy or breastfeeding
  • Patient under legal protection
  • No affiliation to health insurance
  • Secondary exclusion criteria
  • - Lack of access route for catheterization

结局指标

主要结局

Complete recanalization percentage

时间窗: Immediately after the revascularization procedure is completed

Proportion of patients in which complete recanalization is achieved as defined by a TICI score equal to 2b or 3

次要结局

未报告次要终点

研究者

申办方类型
Network
责任方
Sponsor

研究点 (8)

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