ACTRN12612000302853已完成未知
In multiple sclerosis patients with extracranial and/or azygos vein stenosis, is percutaneous balloon angioplasty more effective than a sham procedure in terms of changes to physical, neurological and cognitive function?
The Alfred Hospital0 个研究点目标入组 160 人开始时间: 2012年3月16日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 160
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 65 Years（—）
- 性别
- All
入选标准
- •*Signed Participant Information and Consent Form;
- •*Age 18 to 65 years;
- •*Expanded Disability Disease Scale Score (EDSS) ranging from 0 to 7.5;
- •*Diagnosis of MS according to the revised McDonald criteria;
- •*Therapy with currently approved disease-modifying treatments;
- •*Normal renal function or pre-hydration;
- •*No allergy to contrast media or pre-treatment;
- •*Abnormal extracranial vein venogram:
- •1.Stenosis at any level
- •2.Abnormal filling of vertebral veins following a jugular bulb injection
- •3.Delayed emptying of the internal jugular vein in the supine position
- •4.Persistent filling of the internal jugular vein in the erect position
- •5.Abnormal appearance of the internal jugular valve
- •6.Stenosis of the thoracic azygos vein
- •7.Delayed emptying of the thoracic azygos vein.
排除标准
- •*pregnancy or planning a pregnancy within the next two years
- •*Relapse, disease progression, and steroid treatment in the 30 days preceding study entry (all conditions significantly modify clinical parameters, rendering unreliable any postoperative assessment);
- •*Pre-existing medical conditions known to be associated with brain pathology, including neurodegenerative disorder, cerebrovascular disease, and history of alcohol abuse; *Abnormal renal function with a calculated e-GFR <60 and pre-hydration not possible;
- •*Allergy to contrast and pre-treatment not possible; *Refusal to undergo the endovascular treatment or randomisation.
- •*Previous PTA on extracranial veins
- •*Unable to adequately perform the CogState cognitive assessment tool because of visual or manual dexterity impairment.
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