Safety and Feasibility of Intravenous Tenecteplase thrombolysis plus Intra-arterial (IA) Tenecteplase thrombolysis in ischaemic stroke patients with medium vessel occlusion (distal M2, 3, 4, ACA, PCA).

orthern Sydney Local Health District0 个研究点目标入组 3 人开始时间: 2021年6月7日最近更新: 2023年9月18日

适应症

试验速览

阶段: 2 期
状态: 终止
发起方
入组人数: 3

研究概览研究设计入排标准研究者记录与标识符相似试验

研究概览

简要总结

All three participants received intra-arterial clot-busting medication following intra-venous thrombolysis with clot-busting medication within 4.5 hours of symptom onset. None of the participants had a bleeding complication or allergic reaction. One of the three participants achieved full re-opening of the blocked vessel, but their clinical outcome did not improve after the procedure due to contributing factors including a rare reaction to contrast (not allergic). The other two participants achieved above 90% re-opening of the blocked vessel and had significantly improved clinical outcomes after the procedure (on day 3 after treatment and 3 months later). Both patients could return to work.

研究设计

研究类型: Interventional
分配方式: Non-randomised trial
主要目的: Treatment
盲法: Open (masking not used)

入排标准

年龄范围: 18 Years 至 o limit（—）
性别: All

入选标准

•1. Patients presenting with acute ischaemic stroke eligible using standard criteria to receive IV thrombolysis within 4.5 hours of stroke onset.
•2. Patient’s age is 18 years or over
•3. Intra-arterial clot retrieval treatment can commence (arterial puncture) within 6 hours of stroke onset.
•4. Willing to provide written (or oral) informed consent.
•Imaging inclusion Criteria
•5. Arterial occlusion on CT-Angiogram or MR-Angiogram of distal MCA (middle cerebral artery) branches (M2, 3, 4), ACA (anterior cerebral artery) or PCA (posterior cerebral artery) or corresponding CT-perfusion deficit

排除标准

•1. Intracranial haemorrhage (ICH) identified by CT or MRI
•2. Rapidly improving symptoms at the discretion of the Investigator.
•3. Pre-stroke mRS equal to or greater than 4
•4. Contraindication to imaging with contrast agents
•5. Any terminal illness such that patient would not be expected to survive more than 1 year.
•6. Any condition that, in the judgment of the investigator could impose hazards to the patient if study therapy is initiated or affect the participation of the patient in the study.
•7. Pregnant women.

研究者

发起方

orthern Sydney Local Health District

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