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临床试验/DRKS00005792
DRKS00005792进行中(未招募)未知

Thrombectomy in patients ineligible for iv tPA - THRI

niversitätsKlinikum HeidelbergNeurologische KlinikAbteilung Neuroradiologie0 个研究点目标入组 4 人开始时间: 2014年5月6日最近更新:
适应症

试验速览

阶段
未知
状态
进行中(未招募)
发起方
入组人数
4

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Randomized controlled study
盲法
Open (masking not used)

入排标准

年龄范围
18 Years 至 80 Years(—)
性别
All

入选标准

  • Moderate to severe stroke (NIHSS>7 and <26)
  • Ineligibility for iv tPA and no prior iv tPA therapy
  • Premorbid mRS 0-1
  • Life expectancy > 6 Months
  • Treatment can be accomplished within 8 hours after stroke onset
  • Informed consent by the patient, legal guardian, or independent physician
  • Imaging criteria:
  • Occlusion of the M1 segment of the middle cerebral artery (MCA), and/or the intracranial segment of the distal internal carotid artery (ICA), determined by MRA or CTA
  • CT and CBV map on CTP or DWI with an ASPECT score of 7-10

排除标准

  • Patient is eligible for and receives IV tPA according to licensing criteria
  • Patient with an INR of >3
  • Patient is an active participant in another drug or device treatment trial for any disease state,
  • or patient is expected to start participation in another drug or device treatment trial while
  • enrolled in this protocol, unless approved by Sponsor.
  • Patient has pre-existing neurological or psychiatric disease that could impede the study results or would confound the neurological or functional evaluations.
  • Patient has carotid dissection, high grade stenosis = 70% proximal to occlusion that requires stenting, or excessive tortuosity to gain access to occlusion, as determined by MRA/ CTA of neck and head.
  • Patient has vascular disease preventing endovascular treatment (e.g. aortic dissection or aneurysm, no arterial transfemoral access)
  • Patient has history of contraindication for contrast medium.
  • Patient is known to have infective endocarditis
  • CT scan or MRI with evidence of: Mass effect or intracranial tumor, or hypodensity on
  • unenhanced CT and CBV drop on CBV maps on CTP, or, alternatively as per institutional
  • standard, restricted diffusion on DWI with an ASPECT score of 6 or less
  • Female of childbearing potential who is known to be pregnant and/or lactating or who has a
  • positive pregnancy test on admission.
  • Patients anticipated life expectancy is less than 6 Months.

研究者

发起方
niversitätsKlinikum HeidelbergNeurologische KlinikAbteilung Neuroradiologie

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