Utility of Chronic Cerebrospinal Venous Insufficiency Percutaneous Angioplasty for Multiple Sclerosis: The Albany Vascular Group Study (Liberation Study)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- Incidence of major adverse events
研究概览
简要总结
This is a single center, multispecialty, randomized double blind placebo control feasibility clinical trial. The purpose is to evaluate the safety, feasibility and efficacy of percutaneous transluminal angioplasty in treating extracranial venous obstructive lesions, and its influence on the clinical outcomes of Multiple Sclerosis (MS) patients that have been found to have chronic cerebrospinal venous insufficiency (CCSVI).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Must be 18 years old or greater and less than or equal to 65 years of age
- •Score of 0 to 7 on the EDSS scale
- •Diagnosis of relapsing remitting or secondary progressive Multiple Sclerosis by a neurologist and confirmed by one of the independent study neurologists
- •Presence of greater than or equal to 50 percent stenosis of the extracranial veins as determined by venogram
- •Informed consent signed by patient
排除标准
- •Patient is unwilling to comply with the follow up
- •Patient is pregnant
- •Diagnosis of primary progressive MS by a certified neurologist confirmed by one of the study neurologists
- •Presence of less than 50 percent stenosis of the extracranial veins as determined by venogram
- •Presence of other medical illnesses or a psychiatric condition that in the opinion of the investigator may cause the subject to be non-compliant with the protocol requirements
- •Life expectancy is less than one year
- •Lack of mental capacity to consent
- •Creatinine level of greater than 2.5 or is dialysis dependant
- •Enrollment in another clinical study
结局指标
主要结局
Incidence of major adverse events
时间窗: 30 days
The evaluation of safety will be defined as the incidence of major adverse events at 30 days following the index procedure. The evaluation of feasibility and efficacy will be determined by those patients that do not have more than 50 percent restenosis within the 30 day time frame.
Neurological assessment of MS
时间窗: 1 year
An independant neurologist will assess the number of MS attacks that have occurred during one year follow up period.
MRI/MRA evaluation of MS lesions, recommended
时间窗: 1 year
Evaluation of imaging to reveal local iron content, change in MS lesions and oxygen saturation changes using conventional MRA/MRI methods by an independant radiologist.
次要结局
- Mortality(1 year)
- Major adverse events(1 year)
- Identification of central venous stenosis(1 year)
研究者
Manish Mehta, MD
Principal Investigator
The Vascular Group, PLLC