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
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