Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been terminated.
Sponsor:
Collaborator:
Center for Vascular Awareness, Albany, New York
Information provided by (Responsible Party):
Manish Mehta, MD, The Vascular Group, PLLC
ClinicalTrials.gov Identifier:
NCT01089686
First received: March 17, 2010
Last updated: March 6, 2012
Last verified: March 2012

March 17, 2010
March 6, 2012
August 2010
October 2012   (final data collection date for primary outcome measure)
  • Incidence of major adverse events [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.
Same as current
Complete list of historical versions of study NCT01089686 on ClinicalTrials.gov Archive Site
  • Mortality [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    All cause mortality will be evaluated through one year.
  • Major adverse events [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Incidence of all major adverse events will be collected for one year.
  • Identification of central venous stenosis [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Evaluation of the correlation between MRV, Duplex Ultrasound and Venogram in identifying central venous stenosis.
Mortality [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
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.
Not Provided
Not Provided
 
Study To Evaluate Treating Chronic Cerebrospinal Venous Insufficiency (CCSVI) in Multiple Sclerosis Patients
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).

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Diagnostic
Multiple Sclerosis
  • 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.
  • 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)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
2
October 2012
October 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01089686
LS10-01
No
Manish Mehta, MD, The Vascular Group, PLLC
Manish Mehta, MD
Center for Vascular Awareness, Albany, New York
Principal Investigator: Manish Mehta, MD, MPH The Vascular Group, PLLC
The Vascular Group, PLLC
March 2012

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