Prospective Randomized Endovascular Therapy in Multiple Sclerosis
Prospective Randomized Endovascular Therapy in Multiple Sclerosis
What it found
Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.
What was tested
Treatment tested
- Venous Angioplasty
Placebo
- Sham Angioplasty
Results by group
Percentage of Patients With Immediate and Short-term SAE
1 month post-procedure
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Venous Angioplasty | 0 Participants | 9 | |
| Angio With no Plasty | 0 Participants | 10 |
Venous Angioplasty
Angio With no Plasty
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| Venous Angioplasty | 9 | 0 (0.0%) | |
| Angio With no Plasty | 10 | 0 (0.0%) |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main measures
Percentage of Patients With Immediate and Short-term SAE
1 month post-procedure
Safety
Who could take part
Relapsing MS · 18 to 65 · EDSS 0 to 6.5
Show the full 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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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 color Doppler (TCD) 2. To study the morphology of the venous anomalies by using intraluminal ultrasound (IVUS). 3. To evaluate preliminary efficacy of endovascular therapy (angioplasty) as measured by clinical (relapse rate, disability progression (EDSS)), sonographic (ECD/TCD) and MRI/MRV parameters. 4. To evaluate change in patients self-reported QOL following the therapeutic angioplasty 5. To evaluate whether changes in QOL, fatigue, MSFC or attention following therapeutic angioplasty are associated with brain changes as measured by functional MRI (fMRI).
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History
Started
Jun 2010
Main results due
Apr 2013
Finished
Apr 2013
Results posted
Aug 2025