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Evaluation of Angioplasty in the Treatment of Chronic Cerebrospinal Venous Insufficiency (CCSVI) in Multiple Sclerosis
Thursday, November 25, 2010 7:46 PM | Ken Torbert Volg link
This study is currently recruiting participants.



Verified by Community Care Physicians, P.C., September 2010



First Received: September 10, 2010
Last Updated: September 20, 2010

History of Changes

























Sponsor:Community Care Physicians, P.C.
Information provided by:Community Care Physicians, P.C.
ClinicalTrials.gov Identifier:NCT01201707









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

























Estimated Enrollment:130
Study Start Date:August 2010
Estimated Study Completion Date:August 2013
Estimated Primary Completion Date:August 2012 (Final data collection date for primary outcome measure)

















Arms


Assigned Interventions



Treatment of CCSVI with Angioplasty: Experimental
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

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.

Observation of CCSVI: Sham Comparator
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

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




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








Contacts











Contact: Barbara MacDowell518-262-5356macdowb@mail.amc.edu
Contact: Katy Regan518-262-5938regank@mail.amc.edu















Locations



























United States, New York
Albany Medical CenterRecruiting
Albany, New York, United States, 12208
Contact: Barbara MacDowell 518-262-5356 macdowb@mail.amc.edu
Principal Investigator: Gary P Siskin, MD
Sub-Investigator: Krupa Pandey, MD
Sub-Investigator: John Dalfino, MD
Sub-Investigator: Kenneth Mandato, MD
Image Care LathamRecruiting
Latham, New York, United States, 12110
Contact: Barbara MacDowell 518-262-5356 macdowb@mail.amc.edu







Sponsors and Collaborators

Community Care Physicians, P.C.





Investigators







Principal Investigator:Gary Siskin, MDAlbany Medical College













More Information

Additional Information:







Practice website with educational materials regarding CCSVI
This link exits the ClinicalTrials.gov site




Publications:

































Responsible Party:Albany Medical Center ( Gary Siskin, MD; Professor and Chairman Department of Radiology )
ClinicalTrials.gov Identifier:NCT01201707
History of Changes

Other Study ID Numbers:2794
Study First Received:September 10, 2010
Last Updated:September 20, 2010
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 November 23, 2010

http://clinicaltrials.gov/ct2/show/NCT01201707