- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01089686
Study To Evaluate Treating Chronic Cerebrospinal Venous Insufficiency (CCSVI) in Multiple Sclerosis Patients
March 6, 2012 updated by: Manish Mehta, MD
Utility of Chronic Cerebrospinal Venous Insufficiency Percutaneous Angioplasty for Multiple Sclerosis: The Albany Vascular Group Study (Liberation Study)
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).
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
2
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New York
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Albany, New York, United States, 12205
- The Vascular Group, PLLC, The Vascular Health Pavillion
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Venoplasty (treatment)
Patients will be randomized to treatment or non-treatment arm with a 2:1 ratio.
Patients who meet the inclusion/exclusion criteria and who are randomized to the treatment arm of the study will receive venoplasty at the time of the diagnostic venogram.
|
Venous access is obtained from the groin through the femoral vein.
The catheter will be advanced into the veins in the neck and chest.
Angiographic images will be taken of the extracranial venous system as well as the azygous vein.
These images will be used to confirm CCSVI.
Venoplasty is performed by inserting an additional catheter with a balloon at the tip.
The balloon will be inflated to open the vessel.
Once dilation of the vessel is confirmed, the venous sheath will be removed and manual compression applied to the groin access.
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Sham Comparator: Sham procedure (non-treatment)
Patients will be randomized to treatment or non-treatment with a 2:1 ratio.
Patients who meet the inclusion/exclusion criteria and who are randomized to the non-treatment arm of the study will receive the diagnostic venogram only.
|
Venous access is obtained from the groin through the femoral vein.
The catheter will be advanced into the veins in the neck and chest.
Angiographic images will be taken of the extracranial venous system as well as the azygous vein.
These images will be used to confirm CCSVI.
Since the patient has been randomized to the non-treatment arm of the trial, the procedure will end without venoplasty.
After completion of the diagnostic venogram, the venous sheath will be removed and manual compression applied to the groin access.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of major adverse events
Time Frame: 30 days
|
The evaluation of safety will be defined as the incidence of major adverse events at 30 days following the index procedure.
The evaluation of feasibility and efficacy will be determined by those patients that do not have more than 50 percent restenosis within the 30 day time frame.
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30 days
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Neurological assessment of MS
Time Frame: 1 year
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An independant neurologist will assess the number of MS attacks that have occurred during one year follow up period.
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1 year
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MRI/MRA evaluation of MS lesions, recommended
Time Frame: 1 year
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Evaluation of imaging to reveal local iron content, change in MS lesions and oxygen saturation changes using conventional MRA/MRI methods by an independant radiologist.
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1 year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mortality
Time Frame: 1 year
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All cause mortality will be evaluated through one year.
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1 year
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Major adverse events
Time Frame: 1 year
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Incidence of all major adverse events will be collected for one year.
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1 year
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Identification of central venous stenosis
Time Frame: 1 year
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Evaluation of the correlation between MRV, Duplex Ultrasound and Venogram in identifying central venous stenosis.
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1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Manish Mehta, MD, MPH, The Vascular Group, PLLC
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2010
Primary Completion (Anticipated)
October 1, 2012
Study Completion (Anticipated)
October 1, 2012
Study Registration Dates
First Submitted
March 17, 2010
First Submitted That Met QC Criteria
March 17, 2010
First Posted (Estimate)
March 18, 2010
Study Record Updates
Last Update Posted (Estimate)
March 7, 2012
Last Update Submitted That Met QC Criteria
March 6, 2012
Last Verified
March 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LS10-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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