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临床试验/NCT04942795
NCT04942795已完成不适用

se of ADAPT Assisted by a Compliant Balloon (ADAPT-AB) When ADAPT Fails for Acute Stroke Thrombectomy

Centre Hospitalier Universitaire de Nice1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2018年11月1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
100
试验地点
1
主要终点
Efficacity to reach the clot site when using an inner balloon

研究概览

简要总结

The superiority of mechanical thrombectomy (MT) in patients with acute ischemic stroke from large vessel occlusion compared to standard medical therapy alone has been demonstrated by several randomized clinical trials and become the standard of care for these patients. A direct aspiration first pass technique (ADAPT) for the endovascular treatment of stroke using a large-bore catheter has been reported to be an effective method of achieving MT. Recent studies reported that ADAPT is as efficient and safe as stent retrievers, with a similar successful recanalization rate, but may have better functional outcomes, fewer procedure related-adverse events, and a tendency for faster revascularization compared to the stent-retriever thrombectomy.

However, navigation of a large-bore aspiration catheter is not always possible due to unsuccessful passage of the ophthalmic artery origin ("ledge effect") or tortuous vascular anatomy. The coaxial technique comprises guiding the large-bore catheter with a smaller inner catheter and can facilitate distal access. However, there is a gap between the inner catheter and the distal tip of the large-bore outer catheter that creates a risk of damaging the vessel wall and causing dissection or subarachnoid hemorrhage. Even with this coaxial technique, it is not always possible to reach the clot site with the large-bore catheter. To decrease the gap between the two catheters, several authors have used, in place of the inner microcatheter, a compliant balloon catheter positioned and inflated at the distal tip of the large-bore catheter. The aim of the present study was to evaluate the safety and efficacy of ADAPT assisted by a compliant balloon (ADAPT-AB) when ADAPT using the coaxial technique fails to reach the clot site.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Endovascular therapy were large arterial occlusions proven by MR angiography,
  • Alberta Stroke Program Early CT Score (ASPECTS) >5 on MRI,
  • Baseline National Institutes of Health Stroke Scale (NIHSS) score >
  • If eligible, patients received intravenous thrombolysis (IVT).
  • Exclusion criteria:
  • Vertebro-basilar occlusion

排除标准

  • 未提供

结局指标

主要结局

Efficacity to reach the clot site when using an inner balloon

时间窗: Day 0

Number of patients for whom the balloon made it possible to reach the clot

次要结局

  • Clinical status at 3 month(Month 3)
  • Endovascular Complication(Day 0)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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