Status:
COMPLETED
Prospective Randomized Endovascular Therapy in Multiple Sclerosis
Lead Sponsor:
University at Buffalo
Collaborating Sponsors:
Volcano Corporation
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
1. To assess the safety of endovascular therapy (balloon angioplasty) for venous stenoses in MS patients with CCSVI as documented by sonographic (extracranial echocolor-Doppler (ECD) and transcranial ...
Eligibility Criteria
Inclusion
- Age 18-65 years
- EDSS 0-6.5
- Diagnosis of relapsing MS according to the McDonald criteria (Polman et al., 2005)
- Be on treatment with currently FDA approved disease-modifying treatments
- Evidence of ≥2 sonographic parameters of suspicious abnormal extracranial cerebral venous outflow (see Table 1 background and 1.5 section)
- Demonstration of venous occlusive disease on cervical MRV
- Normal renal function: creatinine clearance level of \>60:
- Constant= 1.23 for men; 1.04 for women
Exclusion
- • Relapse, disease progression and steroid treatment in the 30 days preceding study entry
- Pre-existing medical conditions known to be associated with brain pathology (e.g., neurodegenerative disorder, cerebrovascular disease, positive history of alcohol abuse, etc.)
- Severe peripheral chronic venous insufficiency
- Abnormal renal function
- Contrast allergy (anaphylaxis)
- Not accepting to undergo the endovascular treatment
- Peripheral Vascular Disease
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2013
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05380362
Start Date
June 1 2010
End Date
April 1 2013
Last Update
August 22 2025
Active Locations (1)
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1
Gates Circle Hospital
Buffalo, New York, United States, 14209