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

N/ATerminatedNCT01201707

Community Care Physicians, P.C.18 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Multiple Sclerosis

Interventions

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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