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| Name | Class |
|---|---|
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
| Multiple Sclerosis Society of Canada | OTHER |
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To investigate the safety and tolerability of balloon venoplasty compared to sham in Multiple Sclerosis patients with Chronic Cerebrospinal Venous Insufficiency (CCSVI) as measured by adverse events occurring within 48 weeks of the procedure.
Overview of study objectives are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Catheter Venography & Balloon Venoplasty | Active Comparator | Patients will undergo catheter venography with balloon venoplasty procedure. |
|
| Catheter Venography Only | Sham Comparator | Patients will undergo catheter venography only. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Catheter venography with balloon venoplasty | Procedure | All eligible patients will undergo catheter venography with balloon venoplasty and/or sham at baseline and at week 48 (i.e. Cross over design) followed by clinical and radiologic observation for a minimum of 48 weeks after each procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | To investigate the safety and tolerability of balloon venoplasty compared to sham in Multiple Sclerosis (MS) patients with CCSVI as measured by adverse events occurring within 48 weeks of the procedure. | 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Outcome | To evaluate the efficacy of balloon venoplasty compared to sham as reflected by patient reported quality of life, pain and fatigue scales 48 weeks after the procedure. | 48 weeks |
| Clinical Outcome |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anthony Traboulsee, MD | University of British Columbia | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vancouver Coastal Health - University of British Columbia Hospital | Vancouver | British Columbia | V6T 2B5 | Canada | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30266886 | Derived | Traboulsee AL, Machan L, Girard JM, Raymond J, Vosoughi R, Hardy BW, Emond F, Gariepy JL, Bone JN, Siskin G, Klass D, Isserow S, Illes J, Sadovnick AD, Li DK. Safety and efficacy of venoplasty in MS: A randomized, double-blind, sham-controlled phase II trial. Neurology. 2018 Oct 30;91(18):e1660-e1668. doi: 10.1212/WNL.0000000000006423. Epub 2018 Sep 28. |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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|
| Catheter venography with balloon venoplasty and balloon | Device |
|
To evaluate the efficacy of balloon venoplasty compared to sham as reflected by physician reported clinical scales 48 weeks after the procedure.
| 48 weeks |
| Clinical Outcome | To evaluate the efficacy of balloon venoplasty compared to sham as reflected by MRI 48 weeks after the procedure. | 48 weeks |
| Clinical Outcome | To evaluate the efficacy of balloon venoplasty compared to sham as reflected by catheter venography 48 weeks after the procedure. | 48 weeks |
| University of Manitoba Health Sciences Centre |
| Winnipeg |
| Manitoba |
| R3A 1R9 |
| Canada |
| Centre Hospitalier de l'Université de Montréal | Montreal | Quebec | H2L 4M1 | Canada |
| CHU de Québec - Hôpital de l'Enfant-Jésus | Québec | Quebec | G1J 1Z4 | Canada |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |