Evaluation of Angioplasty in the Treatment of Chronic Cerebrospinal Venous Insufficiency (CCSVI) in Multiple Sclerosis
| Status: | Completed |
|---|---|
| Conditions: | Cardiology, Neurology, Multiple Sclerosis |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Neurology, Other |
| Healthy: | No |
| Age Range: | 18 - 60 |
| Updated: | 11/30/2013 |
| Start Date: | August 2010 |
| End Date: | August 2013 |
| Contact: | Barbara MacDowell |
| Email: | macdowb@mail.amc.edu |
| Phone: | 518-262-5356 |
The Effectiveness of Endovascular Treatment of Chronic Cerebrospinal Venous Insufficiency (CCSVI) in Patients With Multiple Sclerosis
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.
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
We found this trial at
2
sites
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