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Evaluation of Angioplasty in the Treatment of Chronic Cerebrospinal Venous Insufficiency (CCSVI) in Multiple Sclerosis

This study has been terminated.
(Inability to enroll adequate number of patients)
Sponsor:
Information provided by (Responsible Party):
Gary Siskin, MD, Albany Medical College
ClinicalTrials.gov Identifier:
NCT01201707
First received: September 10, 2010
Last updated: November 25, 2013
Last verified: November 2013

September 10, 2010
November 25, 2013
August 2010
September 2013   (final data collection date for primary outcome measure)
  • Impact of CCSVI treatment on quality of life in patients with MS [ Time Frame: 1 Month ] [ Designated as safety issue: No ]
    This will be assessed using the Multiple Sclerosis Quality of Life-54 (MSQOL-54), which is a health-related quality of life measure that combines generic and MS-specific items into a single, self-report questionnaire.
  • Impact of CCSVI treatment on quality of life in patients with MS [ Time Frame: 3 Months ] [ Designated as safety issue: No ]
    This will be assessed using the Multiple Sclerosis Quality of Life-54 (MSQOL-54), which is a health-related quality of life measure that combines generic and MS-specific items into a single, self-report questionnaire.
  • Impact of CCSVI treatment on quality of life in patients with MS [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
    This will be assessed using the Multiple Sclerosis Quality of Life-54 (MSQOL-54), which is a health-related quality of life measure that combines generic and MS-specific items into a single, self-report questionnaire.
  • Impact of CCSVI treatment on quality of life in patients with MS [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
    This will be assessed using the Multiple Sclerosis Quality of Life-54 (MSQOL-54), which is a health-related quality of life measure that combines generic and MS-specific items into a single, self-report questionnaire.
  • Impact of CCSVI treatment on quality of life in patients with MS [ Time Frame: 18 Months ] [ Designated as safety issue: No ]
    This will be assessed using the Multiple Sclerosis Quality of Life-54 (MSQOL-54), which is a health-related quality of life measure that combines generic and MS-specific items into a single, self-report questionnaire.
  • Impact of CCSVI treatment on quality of life in patients with MS [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
    This will be assessed using the Multiple Sclerosis Quality of Life-54 (MSQOL-54), which is a health-related quality of life measure that combines generic and MS-specific items into a single, self-report questionnaire.
Same as current
Complete list of historical versions of study NCT01201707 on ClinicalTrials.gov Archive Site
  • Clinical significance of CCSVI in MS patients [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    This will be assessed clinically using annualized relapse rates, Expanded Disability Status Scale (EDSS) change and change in the timed 25 foot walk.
  • Superiority of angioplasty to observation for treatment of CCSVI [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    This will be assessed clinically using annualized relapse rates, EDSS change, and change in the timed 25-foot walk
  • Incidence of CCSVI in patients with MS [ Time Frame: 0 Months ] [ Designated as safety issue: No ]
    This will be assessed on the basis of the findings on diagnostic venography of the internal jugular and azygos veins, which is the initial procedure performed in these patients.
  • Safety of endovascular treatment of CCSVI [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
    This is defined as the number and nature of any procedure-related adverse effects
  • Target vessel primary and secondary patency [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Primary patency is the interval following the initial angioplasty procedure until a reintervention is performed to preserve patency. Secondary patency is defined as the interval following the initial angioplasty procedure until treatment of the vein is abandoned due to an inability to treat the original lesion
  • Clinical significance of CCSVI in MS patients [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    This will be assessed clinically using annualized relapse rates, EDSS change and change in the timed 25 foot walk.
  • Clinical significance of CCSVI in MS patients [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    This will be assessed clinically using annualized relapse rates, EDSS change and change in the timed 25 foot walk.
  • Clinical significance of CCSVI in MS patients [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    This will be assessed clinically using annualized relapse rates, EDSS change and change in the timed 25 foot walk.
  • Clinical significance of CCSVI in MS patients [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    This will be assessed clinically using annualized relapse rates, EDSS change and change in the timed 25 foot walk.
  • Superiority of angioplasty to observation for treatment of CCSVI [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
    This will be assessed clinically using annualized relapse rates, EDSS change, and change in the timed 25-foot walk
  • Superiority of angioplasty to observation for treatment of CCSVI [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
    This will be assessed clinically using annualized relapse rates, EDSS change, and change in the timed 25-foot walk
  • Superiority of angioplasty to observation for treatment of CCSVI [ Time Frame: 18 Months ] [ Designated as safety issue: No ]
    This will be assessed clinically using annualized relapse rates, EDSS change, and change in the timed 25-foot walk
  • Superiority of angioplasty to observation for treatment of CCSVI [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
    This will be assessed clinically using annualized relapse rates, EDSS change, and change in the timed 25-foot walk
  • Safety of endovascular treatment of CCSVI [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    This is defined as the number and nature of any procedure-related adverse effects
  • Safety of endovascular treatment of CCSVI [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    This is defined as the number and nature of any procedure-related adverse effects
  • Safety of endovascular treatment of CCSVI [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    This is defined as the number and nature of any procedure-related adverse effects
  • Safety of endovascular treatment of CCSVI [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
    This is defined as the number and nature of any procedure-related adverse effects
  • Safety of endovascular treatment of CCSVI [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    This is defined as the number and nature of any procedure-related adverse effects
  • Target vessel primary and secondary patency [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Primary patency is the interval following the initial angioplasty procedure until a reintervention is performed to preserve patency. Secondary patency is defined as the interval following the initial angioplasty procedure until treatment of the vein is abandoned due to an inability to treat the original lesion
  • Target vessel primary and secondary patency [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Primary patency is the interval following the initial angioplasty procedure until a reintervention is performed to preserve patency. Secondary patency is defined as the interval following the initial angioplasty procedure until treatment of the vein is abandoned due to an inability to treat the original lesion
  • Target vessel primary and secondary patency [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Primary patency is the interval following the initial angioplasty procedure until a reintervention is performed to preserve patency. Secondary patency is defined as the interval following the initial angioplasty procedure until treatment of the vein is abandoned due to an inability to treat the original lesion
  • Target vessel primary and secondary patency [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Primary patency is the interval following the initial angioplasty procedure until a reintervention is performed to preserve patency. Secondary patency is defined as the interval following the initial angioplasty procedure until treatment of the vein is abandoned due to an inability to treat the original lesion
  • Target vessel primary and secondary patency [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Primary patency is the interval following the initial angioplasty procedure until a reintervention is performed to preserve patency. Secondary patency is defined as the interval following the initial angioplasty procedure until treatment of the vein is abandoned due to an inability to treat the original lesion
Same as current
Not Provided
Not Provided
 
Evaluation of Angioplasty in the Treatment of Chronic Cerebrospinal Venous Insufficiency (CCSVI) in Multiple Sclerosis
The Effectiveness of Endovascular Treatment of Chronic Cerebrospinal Venous Insufficiency (CCSVI) in Patients With Multiple Sclerosis

The study is being done to determine if venous angioplasty is an effective treatment for chronic cerebrospinal venous insufficiency (CCSVI). In this condition, areas of narrowing or blockages are present in the internal jugular or azygos veins (veins which drain blood from the central nervous system) and these blockages may be associated with symptoms classically attributed to MS. Therefore, angioplasty may help to improve the symptoms associated with CCSVI and multiple sclerosis (MS). In this study, the investigators will evaluate the effectiveness of angioplasty in the treatment of CCSVI by comparing two the outcomes of two groups of patients: one group with CCSVI diagnosed on a venogram and treated with angioplasty and one group with CCSVI diagnosed on a venogram but not treated. The patients enrolled in this study, and the neurologist evaluating patients after the procedure, will not know whether or not they were treated with angioplasty.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Multiple Sclerosis
  • Procedure: Angioplasty
    In this procedure, a small catheter (tube) that is approximately the size of a piece of spaghetti is introduced into the vein that is narrowed based on the findings of the venogram. This catheter has a small balloon on it. That balloon is inflated across the narrowing within the vein with the goal of increasing the diameter of that vein and improving flow within that vein.
  • Other: Observation
    Patients in this arm will be diagnosed with CCSVI based on venography but will receive no intervention. They will be followed in the same manner as patients treated with angioplasty.
  • Experimental: Treatment of CCSVI with Angioplasty
    At the time of venography, these patients will have had a significant lesion (blockage) in the internal jugular and/or the azygos vein that will be treated with angioplasty.
    Intervention: Procedure: Angioplasty
  • Sham Comparator: Observation of CCSVI
    At the time of venography, these patients will have had a significant lesion (blockage) in the internal jugular and/or the azygos vein that will not be treated with angioplasty. These patients will be observed after treatment and compared to those patients who received treatment.
    Intervention: Other: Observation

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
18
September 2013
September 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients who are willing to comply with the protocol requirements and can be contacted by telephone
  • Patients 18-60 years of age
  • Patients with clinically definite multiple sclerosis by Polman criteria
  • Patients with a history of MS as defined above with an EDSS between 3-6.
  • Patients with a significant stenosis of the internal jugular or azygos vein on the basis of magnetic resonance venography or Doppler ultrasound.

Exclusion Criteria:

  • Patients with renal insufficiency based on an estimated GFR <45
  • Patients with a known severe allergy to iodine or gadolinium-based contrast agents which cannot be adequately pre-medicated
  • Patients with a known allergy to nickel
  • Patients who pregnant
  • Patients with a contraindication to anticoagulation or anti-platelet medication
  • Patients with a contraindication to drugs used for conscious sedation during interventional procedures, including Versed and Fentanyl
  • Patients with a history of deep venous thrombosis of the lower extremities
  • Patients with occlusion of the right and left common femoral veins
  • Patients who have had any changes in their disease modifying drug regimen for MS during the 6 months prior to enrollment in this trial. This would include the addition of any new medications, a change in the dosage of any medications, or the removal of any medications from a patient's drug regimen
  • Patients with a life expectancy <18 months
  • Patients who are currently enrolled or who plan to enroll in other investigations that conflict with follow-up testing or confounds data in this trial
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01201707
2794
Yes
Gary Siskin, MD, Albany Medical College
Community Care Physicians, P.C.
Not Provided
Principal Investigator: Gary Siskin, MD Albany Medical College
Community Care Physicians, P.C.
November 2013

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