Multiple Sclerosis
Conditions
Keywords
Multiple Sclerosis
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 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).
Interventions
OTHERVenous Angioplasty
venous angiogram to look for lesions or flaps and then plastying vessels open.
OTHERSham Angioplasty
Patients will be brought to the angio suite and will not know if they are having the venous angioplasty or not.
Sponsors
Volcano Corporation
University at Buffalo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients With Immediate and Short-term SAE | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Venous Angioplasty Venous Angioplasty: venous angiogram to look for lesions or flaps and then plastying vessels open. | 9 |
| Angio With no Plasty Patients will be brought to the angio suite and given and angio but no plasty although patient will not be aware of which treatment they are having.
Sham Angioplasty: Patients will be brought to the angio suite and will not know if they are having the venous angioplasty or not. | 10 |
| Total | 19 |
Baseline characteristics
| Characteristic | Angio With no Plasty | Total | Venous Angioplasty |
|---|---|---|---|
| Age, Continuous | 44.8 years STANDARD_DEVIATION 10.5 | 44.1 years STANDARD_DEVIATION 9.4 | 43.3 years STANDARD_DEVIATION 8.2 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 10 Participants | 19 Participants | 9 Participants |
| Sex: Female, Male Female | 8 Participants | 13 Participants | 5 Participants |
| Sex: Female, Male Male | 2 Participants | 6 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 3 / 9 | 3 / 10 |
| serious Total, serious adverse events | 0 / 9 | 0 / 10 |
Outcome results
Primary
Percentage of Patients With Immediate and Short-term SAE
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.
Time frame: 1 month post-procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Venous Angioplasty | Percentage of Patients With Immediate and Short-term SAE | 0 Participants |
| Angio With no Plasty | Percentage of Patients With Immediate and Short-term SAE | 0 Participants |