A data registry of the efficacy and safety of Penumbra RED system in patients with acute ischemic stroke secondary to intracranial large vessel occlusion, requiring mechanical thrombectomy.

Penumbra Inc0 个研究点目标入组 100 人开始时间: 2023年12月8日最近更新: 2024年3月4日

适应症

试验速览

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•1.The patient would ordinarily be offered mechanical thrombectomy at the participating site, based on local protocols and standard of care.
•2.The Penumbra RED system was used as the initial device to attempt to perform mechanical thrombectomy.
•3.The neurointerventionist intended to perform aspiration thrombectomy by initially navigating the Penumbra RED catheter to the clot interface without the use of a stent-retriever device.
•4.Stroke disease criteria
•a.Patients presenting with acute ischaemic stroke within 24 hours of stroke onset.
•b.Pre-stroke modified Rankin Score (mRS) score of 0-2.
•c.Patients age equal and greater than 18 years.
•d.NIHSS equal and greater than 5 or dysphasia if NIHSS <5.
•e.CT imaging (non-contrast CT, CT angiography, +/- CT Perfusion) findings appropriate to offer mechanical thrombectomy according to the local investigator and local practices.
•f.Arterial occlusion on CT Angiography (CTA) or MR Angiography (MRA) of the intracranial internal carotid artery (ICA), first the middle cerebral artery segment (MCA-M1), the second middle cerebral artery segment (MCA-M2), or the basilar artery (BA).

•1.Any reason that mechanical thrombectomy would not ordinarily standard of care for this case at the local site (local investigators discretion).
•2.Any intracranial haemorrhage at presentation identified by CT or MRI.
•3.Rapidly improving symptoms at the discretion of the investigator.
•4.Contraindication to imaging with iodinated contrast agents.
•5.Any terminal illness such that the patient would not be expected to survive more than 1 year.
•6.Currently undergoing treatment for cancer.
•7.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.
•8.Pregnant women.

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