Prospective Randomized Endovascular Therapy in Multiple Sclerosis

University at Buffalo1 site in 1 country30 target enrollmentJune 1, 2010

ConditionsMultiple Sclerosis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Multiple Sclerosis
Sponsor: University at Buffalo
Enrollment: 30
Locations: 1
Primary Endpoint: Percentage of Patients With Immediate and Short-term SAE
Status: Completed
Last Updated: 8 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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 color Doppler (TCD)
To study the morphology of the venous anomalies by using intraluminal ultrasound (IVUS).
To evaluate preliminary efficacy of endovascular therapy (angioplasty) as measured by clinical (relapse rate, disability progression (EDSS)), sonographic (ECD/TCD) and MRI/MRV parameters.
To evaluate change in patients self-reported QOL following the therapeutic angioplasty
To evaluate whether changes in QOL, fatigue, MSFC or attention following therapeutic angioplasty are associated with brain changes as measured by functional MRI (fMRI).

Registry

clinicaltrials.gov

Start Date

June 1, 2010

End Date

April 1, 2013

Last Updated

8 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University at Buffalo

Responsible Party

Principal Investigator

Adnan H. Siddiqui

MD, PhD, Associate Professor of Neurosurgery and Radiology

University at Buffalo

Eligibility Criteria

Inclusion Criteria

•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 Criteria

•• 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

Outcomes

Primary Outcomes

Percentage of Patients With Immediate and Short-term SAE

Time Frame: 1 month post-procedure

Percent (%) of patients with Severe Adverse Events (SAE) measured at 1 month (Short term) post-surgical safety outcome in MS patients diagnosed with CCSVI that underwent therapeutic angioplasty. The 95% confidence interval of the SAE rates for immediate and short terms will be obtained by the exact method, respectively. The immediate and short term SAE rates will be analyzed, respectively, using the Fisher's exact test.