Study of PHIL® Embolic System in the Treatment of Intracranial Dural Arteriovenous Fistulas in the Pediatric Population
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Proportion of participants with neurological death or major ipsilateral stroke
研究概览
简要总结
The purpose of this study is to collect information about how the PHIL® Embolic System works in the treatment of intracranial dural arteriovenous fistulas. Data collected in this study will be used to evaluate the safety and probable benefits in treating DAVFs.
The PHIL® Embolic System is a Humanitarian Use Device (HUD). The U.S. Food and Drug Administration (FDA) approved the use of the PHIL Embolic System as a HUD in June 2016.
详细描述
Study design:The study is a prospective, single-center, single-arm, clinical study evaluating outcomes in pediatric subjects with intracranial dural arteriovenous fistulas treated with PHIL® device.
Study purpose: To evaluate the safety and probable benefit of MicroVention, Inc. PHIL® Liquid Embolic material in the treatment of intracranial dural arteriovenous fistulas, alone or as an adjunctive treatment for dAVFs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is <22 years of age
- •Subject and legally authorized representative are willing and capable of complying with all study protocol requirements, including specified follow-up period.
- •Subject's legally authorized representative(s) must sign and date an IRB approved written informed consent prior to initiation of any study procedure
- •Subject has an intracranial dAVF that is deemed appropriate for embolization with PHIL without significantly increased risk to collateral or adjacent territories, OR subject has been previously treated with other embolic materials for dAVF.
排除标准
- •Subject presents with an intracranial mass or is currently undergoing radiation therapy for carcinoma or sarcoma of the head or neck region
- •Subject has known allergies to DMSO (dimethyl sulfoxide), iodine or heparin.
- •Subject with a history of life threatening allergy to contrast media (unless treatment for allergy is tolerated).
- •Female subject is currently pregnant.
- •Subject has an acute or chronic life-threatening illness other than the neurological disease to be treated in this study including but not limited to any malignancy or debilitating autoimmune disease
- •Subject has existing severe or advanced comorbid conditions which significantly increase general anesthesia and/ or surgical risk
- •Evidence of active infection at the time of treatment.
- •Subject has a history of bleeding diathesis or coagulopathy, international normalized ratio (INR) greater than 1.5, or will refuse blood transfusions.
- •Subject weighs ≤ 2.5kg Angiographic
- •Subject has severe calcification or vascular tortuosity that may preclude the safe introduction of the sheath, guiding catheter, or access to the lesion with the microcatheter.
- •Contra-indication to DSA, CT scan or MRI/ MRA
- •History of intracranial vasospasm not responsive to medical therapy
- •Extra-cranial stenosis or parent vessel stenosis > 50% proximal to the target lesion to be treated.
- •Subject has a propensity to contrast induced renal injury or a potential to nephrogenic systemic fibrosis
结局指标
主要结局
Proportion of participants with neurological death or major ipsilateral stroke
时间窗: 12 months
The proportion of subjects with neurological death or major ipsilateral stroke (defined as a major stroke within the vascular distribution of the vessel targeted for treatment) within 12 months following completion of treatment, reported as one composite data variable
Proportion of participants with angiographic occlusion
时间窗: up to 12 months
Proportion of subjects with Angiographic occlusion of the pre-specified target vessel intended for treatment at procedure following completion of treatment
次要结局
- Injected volume of PHIL(at time of procedure, average of 3-4 hours)
- Incidence of new-onset permanent morbidity(up to 12 months)
- Number of significant technical events(up to 12 months)
- Procedure time(average of 3-4 hours)
- Incidence of new-onset Intracranial hemorrhage (ICH)(up to 12 months)
- Incidence of device-related mortality(at 30 days)
- Incidence of angiographic cure(up to 12 months)
- Radiation exposure time(average of 60 minutes)
- Incidence of device-related adverse events at procedure(Day 1 during procedure)
- Incidence of device-related adverse events at 30 days(at 30 days)
- Incidence of procedure related adverse events(up to 12 months)
- Pediatric NIH Stroke Scale (PedNIHSS)(at 12 months)
- Dosage of Radiation exposure(average of 60 minutes)
- Incidence of cranial neuropathy(up to 12 months)
- The Pediatric Stroke Outcome Measure (PSOM)(at 12 months)
- Number of procedures(up to 6 months)
研究者
Alejandro Berenstein
Professor
Icahn School of Medicine at Mount Sinai