Status:
TERMINATED
Evaluation of Angioplasty in the Treatment of Chronic Cerebrospinal Venous Insufficiency (CCSVI) in Multiple Sclerosis
Lead Sponsor:
Community Care Physicians, P.C.
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18-60 years
Phase:
NA
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 pres...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2013
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT01201707
Start Date
August 1 2010
End Date
September 1 2013
Last Update
November 26 2013
Active Locations (2)
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1
Albany Medical Center
Albany, New York, United States, 12208
2
Image Care Latham
Latham, New York, United States, 12110