Back to resultsEvaluation of Angioplasty in the Treatment of Chronic Cerebrospinal Venous Insufficiency (CCSVI) in Multiple Sclerosis
Primary Purpose
Multiple Sclerosis
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Angioplasty
Observation
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Sclerosis focused on measuring Multiple Sclerosis, Angioplasty, Vein
Eligibility 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
Sites / Locations
- Albany Medical Center
- Image Care Latham
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Treatment of CCSVI with Angioplasty
Observation of CCSVI
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Impact of CCSVI treatment on quality of life in patients with MS
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
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
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
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
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
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
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
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
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
This is defined as the number and nature of any procedure-related adverse effects
Target vessel primary and secondary patency
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
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
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
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
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
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
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
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
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
This is defined as the number and nature of any procedure-related adverse effects
Safety of endovascular treatment of CCSVI
This is defined as the number and nature of any procedure-related adverse effects
Safety of endovascular treatment of CCSVI
This is defined as the number and nature of any procedure-related adverse effects
Safety of endovascular treatment of CCSVI
This is defined as the number and nature of any procedure-related adverse effects
Safety of endovascular treatment of CCSVI
This is defined as the number and nature of any procedure-related adverse effects
Target vessel primary and secondary patency
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
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
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
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
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
Full Information
NCT ID
NCT01201707
First Posted
September 10, 2010
Last Updated
November 25, 2013
Sponsor
Community Care Physicians, P.C.
1. Study Identification
Unique Protocol Identification Number
NCT01201707
Brief Title
Evaluation of Angioplasty in the Treatment of Chronic Cerebrospinal Venous Insufficiency (CCSVI) in Multiple Sclerosis
Official Title
The Effectiveness of Endovascular Treatment of Chronic Cerebrospinal Venous Insufficiency (CCSVI) in Patients With Multiple Sclerosis
Study Type
Interventional
2. Study Status
Record Verification Date
November 2013
Overall Recruitment Status
Terminated
Why Stopped
Inability to enroll adequate number of patients
Study Start Date
August 2010 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
September 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Community Care Physicians, P.C.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Multiple Sclerosis, Angioplasty, Vein
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment of CCSVI with Angioplasty
Arm Type
Experimental
Arm Description
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.
Arm Title
Observation of CCSVI
Arm Type
Sham Comparator
Arm Description
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 Type
Procedure
Intervention Name(s)
Angioplasty
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Observation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Impact of CCSVI treatment on quality of life in patients with MS
Description
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.
Time Frame
1 Month
Title
Impact of CCSVI treatment on quality of life in patients with MS
Description
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.
Time Frame
3 Months
Title
Impact of CCSVI treatment on quality of life in patients with MS
Description
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.
Time Frame
6 Months
Title
Impact of CCSVI treatment on quality of life in patients with MS
Description
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.
Time Frame
12 Months
Title
Impact of CCSVI treatment on quality of life in patients with MS
Description
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.
Time Frame
18 Months
Title
Impact of CCSVI treatment on quality of life in patients with MS
Description
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.
Time Frame
24 Months
Secondary Outcome Measure Information:
Title
Clinical significance of CCSVI in MS patients
Description
This will be assessed clinically using annualized relapse rates, Expanded Disability Status Scale (EDSS) change and change in the timed 25 foot walk.
Time Frame
1 month
Title
Superiority of angioplasty to observation for treatment of CCSVI
Description
This will be assessed clinically using annualized relapse rates, EDSS change, and change in the timed 25-foot walk
Time Frame
1 month
Title
Incidence of CCSVI in patients with MS
Description
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.
Time Frame
0 Months
Title
Safety of endovascular treatment of CCSVI
Description
This is defined as the number and nature of any procedure-related adverse effects
Time Frame
1 month
Title
Target vessel primary and secondary patency
Description
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
Time Frame
1 month
Title
Clinical significance of CCSVI in MS patients
Description
This will be assessed clinically using annualized relapse rates, EDSS change and change in the timed 25 foot walk.
Time Frame
6 months
Title
Clinical significance of CCSVI in MS patients
Description
This will be assessed clinically using annualized relapse rates, EDSS change and change in the timed 25 foot walk.
Time Frame
12 months
Title
Clinical significance of CCSVI in MS patients
Description
This will be assessed clinically using annualized relapse rates, EDSS change and change in the timed 25 foot walk.
Time Frame
18 months
Title
Clinical significance of CCSVI in MS patients
Description
This will be assessed clinically using annualized relapse rates, EDSS change and change in the timed 25 foot walk.
Time Frame
24 months
Title
Superiority of angioplasty to observation for treatment of CCSVI
Description
This will be assessed clinically using annualized relapse rates, EDSS change, and change in the timed 25-foot walk
Time Frame
6 Months
Title
Superiority of angioplasty to observation for treatment of CCSVI
Description
This will be assessed clinically using annualized relapse rates, EDSS change, and change in the timed 25-foot walk
Time Frame
12 Months
Title
Superiority of angioplasty to observation for treatment of CCSVI
Description
This will be assessed clinically using annualized relapse rates, EDSS change, and change in the timed 25-foot walk
Time Frame
18 Months
Title
Superiority of angioplasty to observation for treatment of CCSVI
Description
This will be assessed clinically using annualized relapse rates, EDSS change, and change in the timed 25-foot walk
Time Frame
24 Months
Title
Safety of endovascular treatment of CCSVI
Description
This is defined as the number and nature of any procedure-related adverse effects
Time Frame
3 months
Title
Safety of endovascular treatment of CCSVI
Description
This is defined as the number and nature of any procedure-related adverse effects
Time Frame
6 months
Title
Safety of endovascular treatment of CCSVI
Description
This is defined as the number and nature of any procedure-related adverse effects
Time Frame
12 months
Title
Safety of endovascular treatment of CCSVI
Description
This is defined as the number and nature of any procedure-related adverse effects
Time Frame
18 months
Title
Safety of endovascular treatment of CCSVI
Description
This is defined as the number and nature of any procedure-related adverse effects
Time Frame
24 months
Title
Target vessel primary and secondary patency
Description
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
Time Frame
3 months
Title
Target vessel primary and secondary patency
Description
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
Time Frame
6 months
Title
Target vessel primary and secondary patency
Description
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
Time Frame
12 months
Title
Target vessel primary and secondary patency
Description
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
Time Frame
18 months
Title
Target vessel primary and secondary patency
Description
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
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gary Siskin, MD
Organizational Affiliation
Albany Medical College
Official's Role
Principal Investigator
Facility Information:
Facility Name
Albany Medical Center
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Image Care Latham
City
Latham
State/Province
New York
ZIP/Postal Code
12110
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
19958985
Citation
Zamboni P, Galeotti R, Menegatti E, Malagoni AM, Gianesini S, Bartolomei I, Mascoli F, Salvi F. A prospective open-label study of endovascular treatment of chronic cerebrospinal venous insufficiency. J Vasc Surg. 2009 Dec;50(6):1348-58.e1-3. doi: 10.1016/j.jvs.2009.07.096. Erratum In: J Vasc Surg. 2010 Apr;51(4):1079.
Results Reference
background
PubMed Identifier
20018140
Citation
Zamboni P, Menegatti E, Weinstock-Guttman B, Schirda C, Cox JL, Malagoni AM, Hojanacki D, Kennedy C, Carl E, Dwyer MG, Bergsland N, Galeotti R, Hussein S, Bartolomei I, Salvi F, Zivadinov R. The severity of chronic cerebrospinal venous insufficiency in patients with multiple sclerosis is related to altered cerebrospinal fluid dynamics. Funct Neurol. 2009 Jul-Sep;24(3):133-8.
Results Reference
background
PubMed Identifier
20351674
Citation
Bartolomei I, Salvi F, Galeotti R, Salviato E, Alcanterini M, Menegatti E, Mascalchi M, Zamboni P. Hemodynamic patterns of chronic cerebrospinal venous insufficiency in multiple sclerosis. Correlation with symptoms at onset and clinical course. Int Angiol. 2010 Apr;29(2):183-8.
Results Reference
background
PubMed Identifier
20351673
Citation
Malagoni AM, Galeotti R, Menegatti E, Manfredini F, Basaglia N, Salvi F, Zamboni P. Is chronic fatigue the symptom of venous insufficiency associated with multiple sclerosis? A longitudinal pilot study. Int Angiol. 2010 Apr;29(2):176-82.
Results Reference
background
PubMed Identifier
19060024
Citation
Zamboni P, Galeotti R, Menegatti E, Malagoni AM, Tacconi G, Dall'Ara S, Bartolomei I, Salvi F. Chronic cerebrospinal venous insufficiency in patients with multiple sclerosis. J Neurol Neurosurg Psychiatry. 2009 Apr;80(4):392-9. doi: 10.1136/jnnp.2008.157164. Epub 2008 Dec 5.
Results Reference
background
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Evaluation of Angioplasty in the Treatment of Chronic Cerebrospinal Venous Insufficiency (CCSVI) in Multiple Sclerosis
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