NCT05380362已完成不适用
Prospective Randomized Endovascular Therapy in Multiple Sclerosis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 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
- To assess the safety of endovascular therapy (balloon angioplasty) for venous stenoses in MS patients with CCSVI as documented by sonographic (extracranial echocolor-Doppler (ECD) and transcranial color Doppler (TCD)
- To study the morphology of the venous anomalies by using intraluminal ultrasound (IVUS).
- To evaluate preliminary efficacy of endovascular therapy (angioplasty) as measured by clinical (relapse rate, disability progression (EDSS)), sonographic (ECD/TCD) and MRI/MRV parameters.
- To evaluate change in patients self-reported QOL following the therapeutic angioplasty
- To evaluate whether changes in QOL, fatigue, MSFC or attention following therapeutic angioplasty are associated with brain changes as measured by functional MRI (fMRI).
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
- 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
- 否
入选标准
- •Age 18-65 years
- •EDSS 0-6.5
- •Diagnosis of relapsing MS according to the McDonald criteria (Polman et al., 2005)
- •Be on treatment with currently FDA approved disease-modifying treatments
- •Evidence of ≥2 sonographic parameters of suspicious abnormal extracranial cerebral venous outflow (see Table 1 background and 1.5 section)
- •Demonstration of venous occlusive disease on cervical MRV
- •Normal renal function: creatinine clearance level of >60:
- •Constant= 1.23 for men; 1.04 for women
排除标准
- •• Relapse, disease progression 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: 1 month post-procedure
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
未报告次要终点
研究者
Adnan H. Siddiqui
MD, PhD, Associate Professor of Neurosurgery and Radiology
University at Buffalo
研究点 (2)
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