The Effectiveness of Endovascular Treatment of Chronic Cerebrospinal Venous Insufficiency (CCSVI) in Patients With Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 18
- 试验地点
- 4
- 主要终点
- Impact of CCSVI treatment on quality of life in patients with MS
研究概览
简要总结
The study is being done to determine if venous angioplasty is an effective treatment for chronic cerebrospinal venous insufficiency (CCSVI). In this condition, areas of narrowing or blockages are present in the internal jugular or azygos veins (veins which drain blood from the central nervous system) and these blockages may be associated with symptoms classically attributed to MS. Therefore, angioplasty may help to improve the symptoms associated with CCSVI and multiple sclerosis (MS). In this study, the investigators will evaluate the effectiveness of angioplasty in the treatment of CCSVI by comparing two the outcomes of two groups of patients: one group with CCSVI diagnosed on a venogram and treated with angioplasty and one group with CCSVI diagnosed on a venogram but not treated. The patients enrolled in this study, and the neurologist evaluating patients after the procedure, will not know whether or not they were treated with angioplasty.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are willing to comply with the protocol requirements and can be contacted by telephone
- •Patients 18-60 years of age
- •Patients with clinically definite multiple sclerosis by Polman criteria
- •Patients with a history of MS as defined above with an EDSS between 3-
- •Patients with a significant stenosis of the internal jugular or azygos vein on the basis of magnetic resonance venography or Doppler ultrasound.
排除标准
- •Patients with renal insufficiency based on an estimated GFR <45
- •Patients with a known severe allergy to iodine or gadolinium-based contrast agents which cannot be adequately pre-medicated
- •Patients with a known allergy to nickel
- •Patients who pregnant
- •Patients with a contraindication to anticoagulation or anti-platelet medication
- •Patients with a contraindication to drugs used for conscious sedation during interventional procedures, including Versed and Fentanyl
- •Patients with a history of deep venous thrombosis of the lower extremities
- •Patients with occlusion of the right and left common femoral veins
- •Patients who have had any changes in their disease modifying drug regimen for MS during the 6 months prior to enrollment in this trial. This would include the addition of any new medications, a change in the dosage of any medications, or the removal of any medications from a patient's drug regimen
- •Patients with a life expectancy <18 months
- •Patients who are currently enrolled or who plan to enroll in other investigations that conflict with follow-up testing or confounds data in this trial
结局指标
主要结局
Impact of CCSVI treatment on quality of life in patients with MS
时间窗: 24 Months
This will be assessed using the Multiple Sclerosis Quality of Life-54 (MSQOL-54), which is a health-related quality of life measure that combines generic and MS-specific items into a single, self-report questionnaire.
次要结局
- Clinical significance of CCSVI in MS patients(24 months)
- Safety of endovascular treatment of CCSVI(24 months)
- Superiority of angioplasty to observation for treatment of CCSVI(24 Months)
- Target vessel primary and secondary patency(24 months)
- Incidence of CCSVI in patients with MS(0 Months)
研究者
Gary Siskin, MD
Professor and Chairman, Department of Radiology
Albany Medical College