Clinical trial NCT01201707: 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
Overall status: TERMINATED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Multiple Sclerosis
Angioplasty
Vein
Lead sponsor: Community Care Physicians, P.C.
Sponsor class: OTHER
First posted: 2010-09-15
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Impact of CCSVI treatment on quality of life in patients with MS
timeFrame: 1 Month
measure: Impact of CCSVI treatment on quality of life in patients with MS
timeFrame: 3 Months
measure: Impact of CCSVI treatment on quality of life in patients with MS
timeFrame: 6 Months
measure: Impact of CCSVI treatment on quality of life in patients with MS
timeFrame: 12 Months
measure: Impact of CCSVI treatment on quality of life in patients with MS
timeFrame: 18 Months
measure: Impact of CCSVI treatment on quality of life in patients with MS
timeFrame: 24 Months
Secondary outcomes:
measure: Clinical significance of CCSVI in MS patients
timeFrame: 1 month
measure: Superiority of angioplasty to observation for treatment of CCSVI
timeFrame: 1 month
measure: Incidence of CCSVI in patients with MS
timeFrame: 0 Months
measure: Safety of endovascular treatment of CCSVI
timeFrame: 1 month
measure: Target vessel primary and secondary patency
timeFrame: 1 month
measure: Clinical significance of CCSVI in MS patients
timeFrame: 6 months
measure: Clinical significance of CCSVI in MS patients
timeFrame: 12 months
measure: Clinical significance of CCSVI in MS patients
timeFrame: 18 months
measure: Clinical significance of CCSVI in MS patients
timeFrame: 24 months
measure: Superiority of angioplasty to observation for treatment of CCSVI
timeFrame: 6 Months
measure: Superiority of angioplasty to observation for treatment of CCSVI
timeFrame: 12 Months
measure: Superiority of angioplasty to observation for treatment of CCSVI
timeFrame: 18 Months
measure: Superiority of angioplasty to observation for treatment of CCSVI
timeFrame: 24 Months
measure: Safety of endovascular treatment of CCSVI
timeFrame: 3 months
measure: Safety of endovascular treatment of CCSVI
timeFrame: 6 months
measure: Safety of endovascular treatment of CCSVI
timeFrame: 12 months
measure: Safety of endovascular treatment of CCSVI
timeFrame: 18 months
measure: Safety of endovascular treatment of CCSVI
timeFrame: 24 months
measure: Target vessel primary and secondary patency
timeFrame: 3 months
measure: Target vessel primary and secondary patency
timeFrame: 6 months
measure: Target vessel primary and secondary patency
timeFrame: 12 months
measure: Target vessel primary and secondary patency
timeFrame: 18 months
measure: Target vessel primary and secondary patency
timeFrame: 24 months
Other outcomes:
Locations:
city: Albany
country: United States
facility: Albany Medical Center
state: New York
city: Latham
country: United States
facility: Image Care Latham
state: New York
Study officials:
affiliation: Albany Medical College
name: Gary Siskin, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.