Study To Evaluate Treating Chronic Cerebrospinal Venous Insufficiency (CCSVI) in Multiple Sclerosis Patients
Stopped early · Not applicable · Has a placebo group
Conditions studied: Multiple Sclerosis
In brief
This is a single center, multispecialty, randomized double blind placebo control feasibility clinical trial. The purpose is to evaluate the safety, feasibility and efficacy of percutaneous transluminal angioplasty in treating extracranial venous obstructive lesions, and its influence on the clinical outcomes of Multiple Sclerosis (MS) patients that have been found to have chronic cerebrospinal venous insufficiency (CCSVI).
Key facts
- Study ID
- NCT01089686
- Run by
- Manish Mehta, MD
- People needed
- 2
- Starts
- 2010-08-01
- Expected to finish
- 2012-10-01
- Last updated by the study team
- 2012-03-07
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Must be 18 years old or greater and less than or equal to 65 years of age
- Score of 0 to 7 on the EDSS scale
- Diagnosis of relapsing remitting or secondary progressive Multiple Sclerosis by a neurologist and confirmed by one of the independent study neurologists
- Presence of greater than or equal to 50 percent stenosis of the extracranial veins as determined by venogram
- Informed consent signed by patient
You may not qualify if…
- Patient is unwilling to comply with the follow up
- Patient is pregnant
- Diagnosis of primary progressive MS by a certified neurologist confirmed by one of the study neurologists
- Presence of less than 50 percent stenosis of the extracranial veins as determined by venogram
- Presence of other medical illnesses or a psychiatric condition that in the opinion of the investigator may cause the subject to be non-compliant with the protocol requirements
- Life expectancy is less than one year
- Lack of mental capacity to consent
- Creatinine level of greater than 2.5 or is dialysis dependant
- Enrollment in another clinical study
Where it is running
- The Vascular Group, PLLC, The Vascular Health Pavillion — Albany, New York, United States
Full record on ClinicalTrials.gov
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