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
  Purpose

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.


Condition Intervention
Multiple Sclerosis
Procedure: Angioplasty
Other: Observation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effectiveness of Endovascular Treatment of Chronic Cerebrospinal Venous Insufficiency (CCSVI) in Patients With Multiple Sclerosis

Resource links provided by NLM:


Further study details as provided by Community Care Physicians, P.C.:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Enrollment: 18
Study Start Date: August 2010
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
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.
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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01201707

Locations
United States, New York
Albany Medical Center
Albany, New York, United States, 12208
Image Care Latham
Latham, New York, United States, 12110
Sponsors and Collaborators
Community Care Physicians, P.C.
Investigators
Principal Investigator: Gary Siskin, MD Albany Medical College
  More Information

Additional Information:
Publications:
Responsible Party: Gary Siskin, MD, Professor and Chairman, Department of Radiology, Albany Medical College
ClinicalTrials.gov Identifier: NCT01201707     History of Changes
Other Study ID Numbers: 2794
Study First Received: September 10, 2010
Last Updated: November 25, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Community Care Physicians, P.C.:
Multiple Sclerosis
Angioplasty
Vein

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Venous Insufficiency
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 29, 2014