Pivotal Study of the Treatment of Symptomatic Subacute and Chronic Subdural Hematoma Via Middle Meningeal Artery Embolization With the NeoCastTM Embolic System (RADIANT)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 360
- 试验地点
- 2
- 主要终点
- Comparison of NeoCast arm vs. FDA-approved commercial liquid embolic for demonstration of successful embolization of the middle meningeal artery
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of embolization of the middle meningeal artery (MMA) using the NeoCast Embolic System for treatment of symptomatic subacute or chronic subdural hematoma (SDH) adjunctive to surgery.
详细描述
This is a prospective, multi-center, randomized, controlled, single-blind pivotal trial to evaluate the safety and effectiveness of the NeoCast Embolic System in embolization of the middle meningeal artery (MMA) in surgically treated patients with symptomatic subacute or chronic SDH. Three hundred sixty participants will be randomized in a 2:1 ratio to be embolized with either the Arsenal Medical NeoCast Embolic System or Onyx LES, an FDA-approved commercial embolic. The Primary Effectiveness Endpoint will be measured at the 90-day timepoint post-treatment. Participants will be followed through 180 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Independent Imaging Core Lab
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant whose age is ≥ 18 and ≤ 90 years;
- •Pre-morbid mRS ≤ 2;
- •Confirmed diagnosis of subacute or chronic subdural hematoma that measures ≥10 mm in greatest thickness;
- •Participant presents with one or more of the following corroborating neurological symptoms: headache; cognitive decline; speech difficulty; gait impairment or imbalance; focal neurological deficit; and/or seizure, within the last 30 days;
- •Participant is planned for middle meningeal artery embolization within ±7 days of surgical evacuation of hematoma via burr hole or craniotomy;
- •Participant or Legally Authorized Representative/Person Responsible for consenting on their behalf understands the nature of the procedure, consents to participation in the study and provides a signed informed consent form;
- •Participant (woman of child-bearing potential) with a current negative pregnancy test who has agreed to an appropriate method of contraception throughout the trial;
- •Participant is willing to return to the investigational site for follow-up visits.
排除标准
- •Diagnosed with acute SDH
- •Participant with prior embolization of either MMA
- •Participant with urgent or emergent (within 1 hour of assessment) subdural hematoma evacuation needed
- •Participant with bilateral SDH where both sides require surgery or contralateral SDH >5mm in greatest thickness
- •Participant identified with potentially dangerous anatomic variations leading to increased procedural risk, risk of incomplete embolization, or unsafe access for MMA embolization (i.e., MMA originating from ophthalmic artery)
- •Participant who presents with a meningioma ≥1 cm or < 1 cm with mass effect
- •Subjects with conditions placing them at high-risk for ischemic stroke who cannot be taken off anticoagulants for at least 7 days post-surgery
- •Participant currently undergoing radiation therapy for carcinoma or sarcomas of the head or neck region
- •SDH developed due to underlying condition or structure pathology (e.g., dural AV fistula, AVM, tumor, arachnoid cyst, ventriculoperitoneal shunt, spontaneous intracranial hypotension or previous craniotomy)
- •Presumed microbial superinfection
- •Participant who is breastfeeding
- •Participant with life expectancy of <1 year
- •Participants with acute renal impairment that the investigator assesses could be at risk for contrast induced nephropathy
- •Participant 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 or the Onyx LES commercial embolic device
- •Participant who is currently participating or planning to participate within 6 months in another clinical research study
研究组 & 干预措施
NeoCast Embolic System
Participants randomized to the NeoCast arm will have their MMA embolized with NeoCast adjunctive to surgery
干预措施: NeoCast Embolic System (Device)
结局指标
主要结局
Comparison of NeoCast arm vs. FDA-approved commercial liquid embolic for demonstration of successful embolization of the middle meningeal artery
时间窗: 90 Days post-treatment
Comparison of NeoCast arm vs. FDA-approved commercial liquid embolic for demonstration of successful embolization of the middle meningeal artery which is defined by meeting all the following criteria: * Distribution of the embolic material in the distal 50% of the MMA branches (assessed by a blinded, independent Imaging Core Lab); * Avoidance of SDH recurrence/progression requiring ipsilateral surgical drainage through 90 days (CEC adjudicated); * Avoidance of neurological disabling SAE related to the device and/or embolization procedure through 30 days (CEC adjudicated)
Safety Outcomes including Device-related or Procedure-related Serious Adverse Events
时间窗: 180 days post-treatment
CEC-adjudicated safety outcomes in both arms including: * Incidence of device-related Serious Adverse Events * Incidence of embolization procedure-related Serious Adverse Events * Incidence of device-related neurological deaths or disabling strokes within 30 days of embolization procedure * Incidence of device-related Adverse Events
次要结局
- Superiority evaluation of percent hematoma volume reduction at 30 days compared to post-treatment timepoint comparing the NeoCast arm to the active comparator arm(30 days post-treatment)
- Superiority evaluation for successful distal penetration comparing NeoCast arm to the active comparator arm(Peri-procedural)
- Superiority evaluation for successful embolization comparing NeoCast arm to the active comparator arm(90 days post-treatment)
- Superiority evaluation of complete hematoma resolution at 180 days comparing the NeoCast arm to the active comparator arm(180 days post-treatment)