First in Human Study of the Safety and Feasibility of Middle Meningeal Artery (MMA) Embolisation with the Arsenal Medical NeoCast Embolic System for the Treatment of Chronic Subdural Hematoma (cSDH)

Arsenal Medical Australia Pty Ltd.0 个研究点目标入组 10 人开始时间: 2024年5月22日最近更新: 2024年5月27日

适应症

试验速览

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•Subject whose age is greater than or equal to 18 years and less than or equal to 90 years;
•Subject whose pre-morbid mRS score is less than or equal to 2
•Confirmed diagnosis of a symptomatic chronic subdural hematoma that measures greater than or equal to 10 mm in greatest thickness
•Subject is planned for Middle Meningeal Artery embolisation for cSDH, either adjunctive to surgery or as part of medical management
•Subject understands the nature of the procedure, consents to participation in the study and provides a signed informed consent form;
•Subject (woman of child-bearing potential) with a current negative pregnancy test who has agreed to an appropriate method of contraception throughout the trial;
•Subject is willing to return to the investigational site for follow-up visits.
•Baseline Inclusion Criteria:
•A negative pregnancy test is required at baseline for a woman of child-bearing potential

•Screening Exclusion Criteria:
•Diagnosed with acute SDH
•Subject with prior embolisation of either MMA
•Subject with urgent or emergent (within 1 hour of assessment) subdural hematoma evacuation needed
•Subject who presents with a meningioma greater than or equal to 1 cm or less than 1 cm with mass effect
•Subject currently undergoing radiation therapy for carcinoma or sarcoma of the head or neck region
•Structural pathology causing the cSDH (e.g., dural AV fistula, AVM, tumor, arachnoid cyst, ventriculoperitoneal shunt)
•Presumed microbial superinfection
•Subject who is breastfeeding
•Subject with life expectancy of less than 1 year
•Patients with acute renal impairment that the investigator assesses could be at risk for contrast induced nephropathy
•Subject with a life-threatening allergy to radiographic contrast (unless treatment for allergy is tolerated or can be managed medically)
•Participant is allergic to any of the materials used in the NeoCast device
•Planned embolisation procedure that would require use of a microcatheter with lumen diameter < 0.016 in
•Subject who is currently participating or planning to participate within 6 months in another non-observational clinical research study
•Baseline Exclusion Criteria:
•Digital subtractive angiography (DSA) demonstrates potentially dangerous anatomic variations leading to increased procedural risk or unsafe access for MMA embolisation (i.e., MMA originating from ophthalmic artery)

发起方

Arsenal Medical Australia Pty Ltd.