N/A Completed N=20 Randomized Single-blind Treatment

Prospective Randomized Endovascular Therapy in Multiple Sclerosis - PREMiSE

Multiple Sclerosis

Source: ClinicalTrials.gov NCT01450072 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2025

Primary outcomePrimary: Percentage of Patients With Immediate and Short-term SAE — 0; 0 Participants

Summary

The Departments of Neurology and Neurosurgery are conducting this research study to evaluate the safety and effectiveness of intravascular angioplasty for the treatment of venous narrowing in the treatment of Multiple Sclerosis (MS).

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Patients With Immediate and Short-term SAE	0; 0	—
SECONDARY Number of Participants With More Than 75% of Normal Outflow at 1 Year Post-angioplasty	0; 0	—

Eligibility Criteria

Inclusion Criteria

Age 18-65 years
EDSS 0-6.5 (0-5.5 in the phase II of the study)
Diagnosis of relapsing MS according to the McDonald criteria (Polman et al., 2005)
1 relapse within the past 12 months or GAD positive lesion on an MRI within the past 3 months (only for phase II of the study)
Be on treatment with currently FDA approved disease-modifying treatments (excluding Tysabri or steroids (within the last 30 days prior to enrollment)
Evidence of ≥2 sonographic parameters of suspicious abnormal extracranial cerebral venous outflow (see Table 1 background and 1.5 section)
Normal renal function: creatinine clearance level of >60

Exclusion Criteria

Relapse, disease progression and Tysabri 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01450072). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.