Phase I/II Interventional Clinical Trial of Balloon Venoplasty for Chronic Cerebrospinal Venous Insufficiency in Multiple Sclerosis Patients
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 104
- 试验地点
- 8
- 主要终点
- Adverse Events
研究概览
简要总结
To investigate the safety and tolerability of balloon venoplasty compared to sham in Multiple Sclerosis patients with Chronic Cerebrospinal Venous Insufficiency (CCSVI) as measured by adverse events occurring within 48 weeks of the procedure.
详细描述
Overview of study objectives are:
- To determine the safety and tolerability of venoplasty of CCSVI in Multiple Sclerosis (MS).
- To determine the short term and long term impact on validated patient measures and by physician and radiologic reported MS outcomes.
- To determine the short term and long term recurrence rate of CCSVI for veins that have been treated with venoplasty
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, 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
- •Diagnosis of Relapsing Remitting Multiple Sclerosis (RRMS) or Secondary Progressive MS according to the McDonald criteria 2010
- •Age 18 to 65 years inclusive
- •Neurostatus (EDSS) score at screening from 0 to 6.5
- •Fulfill ultrasound criteria for CCSVI
排除标准
- •Previous venoplasty and/or stenting of extra cranial venous system
研究组 & 干预措施
Catheter Venography & Balloon Venoplasty
Patients will undergo catheter venography with balloon venoplasty procedure.
干预措施: Catheter venography with balloon venoplasty (Procedure)
Catheter Venography & Balloon Venoplasty
Patients will undergo catheter venography with balloon venoplasty procedure.
干预措施: Catheter venography with balloon venoplasty and balloon (Device)
Catheter Venography Only
Patients will undergo catheter venography only.
干预措施: Catheter venography with balloon venoplasty (Procedure)
结局指标
主要结局
Adverse Events
时间窗: 48 weeks
To investigate the safety and tolerability of balloon venoplasty compared to sham in Multiple Sclerosis (MS) patients with CCSVI as measured by adverse events occurring within 48 weeks of the procedure.
次要结局
- Clinical Outcome(48 weeks)
研究者
Anthony Traboulsee
Principal Investigator
University of British Columbia