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临床试验/NCT01450072
NCT01450072
已完成
不适用

Prospective Randomized Endovascular Therapy in Multiple Sclerosis - PREMiSE

State University of New York at Buffalo1 个研究点 分布在 1 个国家目标入组 20 人2010年6月

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Multiple Sclerosis
发起方
State University of New York at Buffalo
入组人数
20
试验地点
1
主要终点
Percentage of Patients With Immediate and Short-term SAE
状态
已完成
最后更新
10个月前

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).

注册库
clinicaltrials.gov
开始日期
2010年6月
结束日期
2012年12月
最后更新
10个月前
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

责任方
Principal Investigator
主要研究者

Adnan H. Siddiqui

Principal Investigator

State University of New York at Buffalo

入排标准

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)

研究点 (1)

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