Prospective Randomized Endovascular Therapy in Multiple Sclerosis - PREMiSE
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Percentage of Patients With Immediate and Short-term SAE
研究概览
简要总结
The Departments of Neurology and Neurosurgery are conducting this research study to evaluate the safety and effectiveness of intravascular angioplasty for the treatment of venous narrowing in the treatment of Multiple Sclerosis (MS).
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)
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
- 否
入选标准
- •Age 18-65 years
- •EDSS 0-6.5 (0-5.5 in the phase II of the study)
- •Diagnosis of relapsing MS according to the McDonald criteria (Polman et al., 2005)
- •1 relapse within the past 12 months or GAD positive lesion on an MRI within the past 3 months (only for phase II of the study)
- •Be on treatment with currently FDA approved disease-modifying treatments (excluding Tysabri or steroids (within the last 30 days prior to enrollment)
- •Evidence of ≥2 sonographic parameters of suspicious abnormal extracranial cerebral venous outflow (see Table 1 background and 1.5 section)
- •Normal renal function: creatinine clearance level of >60
排除标准
- •Relapse, disease progression and Tysabri and steroid treatment in the 30 days preceding study entry
- •Pre-existing medical conditions known to be associated with brain pathology (e.g., neurodegenerative disorder, cerebrovascular disease, positive history of alcohol abuse, etc.)
- •Severe peripheral chronic venous insufficiency
- •Abnormal renal function
- •Contrast allergy (anaphylaxis)
- •Not accepting to undergo the endovascular treatment
- •Peripheral Vascular Disease
结局指标
主要结局
Percentage of Patients With Immediate and Short-term SAE
时间窗: 24 hours-1 month
Percent (%) of patients with Severe Adverse Events (SAE) measured at 1 month (Short term) post-surgical safety outcome in MS patients diagnosed with CCSVI that underwent therapeutic angioplasty. The 95% confidence interval of the SAE rates for immediate and short terms will be obtained by the exact method, respectively. The immediate and short term SAE rates will be analyzed, respectively, using the Fisher's exact test.
次要结局
- Number of Participants With More Than 75% of Normal Outflow at 1 Year Post-angioplasty(1 month, 3 months, 6 months, and 1 year post-angioplasty)
研究者
Adnan H. Siddiqui
Principal Investigator
State University of New York at Buffalo