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

Multiple Sclerosis Clinical Trial

Official title:

The Effectiveness of Endovascular Treatment of Chronic Cerebrospinal Venous Insufficiency (CCSVI) in Patients With Multiple Sclerosis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01201707
• Other study ID #: 2794
• Status: Terminated
• Phase: N/A
• First received: September 10, 2010
• Last updated: November 25, 2013
• Start date: August 2010
• Est. completion date: September 2013

Study information

• Verified date: November 2013
• Source: Community Care Physicians, P.C.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 18
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis
• Venous Insufficiency

Intervention

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.

Locations

Country	Name	City	State
United States	Albany Medical Center	Albany	New York
United States	Image Care Latham	Latham	New York

Sponsors (1)

Lead Sponsor	Collaborator
Community Care Physicians, P.C.

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 Month	No
Primary	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.	3 Months	No
Primary	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.	6 Months	No
Primary	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.	12 Months	No
Primary	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.	18 Months	No
Primary	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.	24 Months	No
Secondary	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.	1 month	No
Secondary	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	1 month	No
Secondary	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.	0 Months	No
Secondary	Safety of endovascular treatment of CCSVI	This is defined as the number and nature of any procedure-related adverse effects	1 month	Yes
Secondary	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	1 month	No
Secondary	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.	6 months	No
Secondary	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.	12 months	No
Secondary	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.	18 months	No
Secondary	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.	24 months	No
Secondary	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	6 Months	No
Secondary	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	12 Months	No
Secondary	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	18 Months	No
Secondary	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	24 Months	No
Secondary	Safety of endovascular treatment of CCSVI	This is defined as the number and nature of any procedure-related adverse effects	3 months	Yes
Secondary	Safety of endovascular treatment of CCSVI	This is defined as the number and nature of any procedure-related adverse effects	6 months	Yes
Secondary	Safety of endovascular treatment of CCSVI	This is defined as the number and nature of any procedure-related adverse effects	12 months	Yes
Secondary	Safety of endovascular treatment of CCSVI	This is defined as the number and nature of any procedure-related adverse effects	18 months	Yes
Secondary	Safety of endovascular treatment of CCSVI	This is defined as the number and nature of any procedure-related adverse effects	24 months	Yes
Secondary	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	3 months	No
Secondary	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	6 months	No
Secondary	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	12 months	No
Secondary	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	18 months	No
Secondary	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	24 months	No

External Links

•   Practice website with educational materials regarding CCSVI