Study To Evaluate Treating Chronic Cerebrospinal Venous Insufficiency
Utility of Chronic Cerebrospinal Venous Insufficiency Percutaneous Angioplasty for Multiple Sclerosis: The Albany Vascular Group Study (Liberation Study)
What it found
The trial ended early for another reason (see below).
This trial finished 14 years ago. We found no results in the registry or in any paper that cites it.
What was tested
Treatment tested
- Venoplasty
Placebo
- Sham procedure (non-treatment)
What it measured
Main measures
Incidence of major adverse events
30 days
SafetyFeasibilityNeurological assessment of MS
1 year
RelapsesMRI/MRA evaluation of MS lesions, recommended
1 year
MRI lesions
Other measures (3)
Mortality
1 year
Major adverse events
1 year
SafetyIdentification of central venous stenosis
1 year
Who could take part
Relapsing and progressive · 18 to 65
Show the full criteria
Inclusion criteria
* 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
Exclusion criteria
* 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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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).
Papers
Loading reviews and guidelines…
History
Started
Aug 2010
Main results due
Oct 2012
Finished
Oct 2012