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Study To Evaluate Treating Chronic Cerebrospinal Venous Insufficiency (CCSVI) in Multiple Sclerosis Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01089686
Recruitment Status : Terminated
First Posted : March 18, 2010
Last Update Posted : March 7, 2012
Sponsor:
Collaborator:
Center for Vascular Awareness, Albany, New York
Information provided by (Responsible Party):
Manish Mehta, MD, The Vascular Group, PLLC

Tracking Information
First Submitted Date  ICMJE March 17, 2010
First Posted Date  ICMJE March 18, 2010
Last Update Posted Date March 7, 2012
Study Start Date  ICMJE August 2010
Estimated Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 21, 2011)
  • 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.
  • Neurological assessment of MS [ Time Frame: 1 year ]
    An independant neurologist will assess the number of MS attacks that have occurred during one year follow up period.
  • MRI/MRA evaluation of MS lesions, recommended [ Time Frame: 1 year ]
    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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 17, 2010)
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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 30, 2010)
  • Mortality [ Time Frame: 1 year ]
    All cause mortality will be evaluated through one year.
  • Major adverse events [ Time Frame: 1 year ]
    Incidence of all major adverse events will be collected for one year.
  • Identification of central venous stenosis [ Time Frame: 1 year ]
    Evaluation of the correlation between MRV, Duplex Ultrasound and Venogram in identifying central venous stenosis.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 17, 2010)
Mortality [ Time Frame: 2 years ]
Secondary endpoints will be evaluated with all subjects based upon mortality, incidence of all secondary interventions and incidence of all major adverse events for a period of 2 years.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study To Evaluate Treating Chronic Cerebrospinal Venous Insufficiency (CCSVI) in Multiple Sclerosis Patients
Official Title  ICMJE Utility of Chronic Cerebrospinal Venous Insufficiency Percutaneous Angioplasty for Multiple Sclerosis: The Albany Vascular Group Study (Liberation Study)
Brief Summary 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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Diagnostic
Condition  ICMJE Multiple Sclerosis
Intervention  ICMJE
  • Procedure: Venoplasty
    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.
  • Procedure: Sham procedure (non-treatment)
    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.
Study Arms  ICMJE
  • 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.
    Intervention: Procedure: Venoplasty
  • 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.
    Intervention: Procedure: Sham procedure (non-treatment)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: March 6, 2012)
2
Original Estimated Enrollment  ICMJE
 (submitted: March 17, 2010)
500
Estimated Study Completion Date  ICMJE October 2012
Estimated Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01089686
Other Study ID Numbers  ICMJE LS10-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Manish Mehta, MD, The Vascular Group, PLLC
Study Sponsor  ICMJE Manish Mehta, MD
Collaborators  ICMJE Center for Vascular Awareness, Albany, New York
Investigators  ICMJE
Principal Investigator: Manish Mehta, MD, MPH The Vascular Group, PLLC
PRS Account The Vascular Group, PLLC
Verification Date March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP