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Inability to enroll adequate number of patients
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The study is being done to determine if venous angioplasty is an effective treatment for chronic cerebrospinal venous insufficiency (CCSVI). In this condition, areas of narrowing or blockages are present in the internal jugular or azygos veins (veins which drain blood from the central nervous system) and these blockages may be associated with symptoms classically attributed to MS. Therefore, angioplasty may help to improve the symptoms associated with CCSVI and multiple sclerosis (MS). In this study, the investigators will evaluate the effectiveness of angioplasty in the treatment of CCSVI by comparing two the outcomes of two groups of patients: one group with CCSVI diagnosed on a venogram and treated with angioplasty and one group with CCSVI diagnosed on a venogram but not treated. The patients enrolled in this study, and the neurologist evaluating patients after the procedure, will not know whether or not they were treated with angioplasty.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment of CCSVI with Angioplasty | Experimental | At the time of venography, these patients will have had a significant lesion (blockage) in the internal jugular and/or the azygos vein that will be treated with angioplasty. |
|
| Observation of CCSVI | Sham Comparator | At the time of venography, these patients will have had a significant lesion (blockage) in the internal jugular and/or the azygos vein that will not be treated with angioplasty. These patients will be observed after treatment and compared to those patients who received treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Angioplasty | Procedure | In this procedure, a small catheter (tube) that is approximately the size of a piece of spaghetti is introduced into the vein that is narrowed based on the findings of the venogram. This catheter has a small balloon on it. That balloon is inflated across the narrowing within the vein with the goal of increasing the diameter of that vein and improving flow within that vein. |
| Measure | Description | Time Frame |
|---|---|---|
| Impact of CCSVI treatment on quality of life in patients with MS | This will be assessed using the Multiple Sclerosis Quality of Life-54 (MSQOL-54), which is a health-related quality of life measure that combines generic and MS-specific items into a single, self-report questionnaire. | 1 Month |
| Impact of CCSVI treatment on quality of life in patients with MS | This will be assessed using the Multiple Sclerosis Quality of Life-54 (MSQOL-54), which is a health-related quality of life measure that combines generic and MS-specific items into a single, self-report questionnaire. | 3 Months |
| Impact of CCSVI treatment on quality of life in patients with MS | This will be assessed using the Multiple Sclerosis Quality of Life-54 (MSQOL-54), which is a health-related quality of life measure that combines generic and MS-specific items into a single, self-report questionnaire. | 6 Months |
| Impact of CCSVI treatment on quality of life in patients with MS | This will be assessed using the Multiple Sclerosis Quality of Life-54 (MSQOL-54), which is a health-related quality of life measure that combines generic and MS-specific items into a single, self-report questionnaire. | 12 Months |
| Impact of CCSVI treatment on quality of life in patients with MS | This will be assessed using the Multiple Sclerosis Quality of Life-54 (MSQOL-54), which is a health-related quality of life measure that combines generic and MS-specific items into a single, self-report questionnaire. | 18 Months |
| Impact of CCSVI treatment on quality of life in patients with MS |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical significance of CCSVI in MS patients | This will be assessed clinically using annualized relapse rates, Expanded Disability Status Scale (EDSS) change and change in the timed 25 foot walk. | 1 month |
| Superiority of angioplasty to observation for treatment of CCSVI |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gary Siskin, MD | Albany Medical College | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Albany Medical Center | Albany | New York | 12208 | United States | ||
| Image Care Latham |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19958985 | Background | Zamboni P, Galeotti R, Menegatti E, Malagoni AM, Gianesini S, Bartolomei I, Mascoli F, Salvi F. A prospective open-label study of endovascular treatment of chronic cerebrospinal venous insufficiency. J Vasc Surg. 2009 Dec;50(6):1348-58.e1-3. doi: 10.1016/j.jvs.2009.07.096. | |
| 20018140 | Background | Zamboni P, Menegatti E, Weinstock-Guttman B, Schirda C, Cox JL, Malagoni AM, Hojanacki D, Kennedy C, Carl E, Dwyer MG, Bergsland N, Galeotti R, Hussein S, Bartolomei I, Salvi F, Zivadinov R. The severity of chronic cerebrospinal venous insufficiency in patients with multiple sclerosis is related to altered cerebrospinal fluid dynamics. Funct Neurol. 2009 Jul-Sep;24(3):133-8. |
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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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| ID | Term |
|---|---|
| D017130 | Angioplasty |
| D019370 | Observation |
| ID | Term |
|---|---|
| D002404 | Catheterization |
| D013812 | Therapeutics |
| D057510 | Endovascular Procedures |
| D014656 | Vascular Surgical Procedures |
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|
| Observation | Other | Patients in this arm will be diagnosed with CCSVI based on venography but will receive no intervention. They will be followed in the same manner as patients treated with angioplasty. |
|
This will be assessed using the Multiple Sclerosis Quality of Life-54 (MSQOL-54), which is a health-related quality of life measure that combines generic and MS-specific items into a single, self-report questionnaire. |
| 24 Months |
This will be assessed clinically using annualized relapse rates, EDSS change, and change in the timed 25-foot walk |
| 1 month |
| Incidence of CCSVI in patients with MS | This will be assessed on the basis of the findings on diagnostic venography of the internal jugular and azygos veins, which is the initial procedure performed in these patients. | 0 Months |
| Safety of endovascular treatment of CCSVI | This is defined as the number and nature of any procedure-related adverse effects | 1 month |
| Target vessel primary and secondary patency | Primary patency is the interval following the initial angioplasty procedure until a reintervention is performed to preserve patency. Secondary patency is defined as the interval following the initial angioplasty procedure until treatment of the vein is abandoned due to an inability to treat the original lesion | 1 month |
| Clinical significance of CCSVI in MS patients | This will be assessed clinically using annualized relapse rates, EDSS change and change in the timed 25 foot walk. | 6 months |
| Clinical significance of CCSVI in MS patients | This will be assessed clinically using annualized relapse rates, EDSS change and change in the timed 25 foot walk. | 12 months |
| Clinical significance of CCSVI in MS patients | This will be assessed clinically using annualized relapse rates, EDSS change and change in the timed 25 foot walk. | 18 months |
| Clinical significance of CCSVI in MS patients | This will be assessed clinically using annualized relapse rates, EDSS change and change in the timed 25 foot walk. | 24 months |
| Superiority of angioplasty to observation for treatment of CCSVI | This will be assessed clinically using annualized relapse rates, EDSS change, and change in the timed 25-foot walk | 6 Months |
| Superiority of angioplasty to observation for treatment of CCSVI | This will be assessed clinically using annualized relapse rates, EDSS change, and change in the timed 25-foot walk | 12 Months |
| Superiority of angioplasty to observation for treatment of CCSVI | This will be assessed clinically using annualized relapse rates, EDSS change, and change in the timed 25-foot walk | 18 Months |
| Superiority of angioplasty to observation for treatment of CCSVI | This will be assessed clinically using annualized relapse rates, EDSS change, and change in the timed 25-foot walk | 24 Months |
| Safety of endovascular treatment of CCSVI | This is defined as the number and nature of any procedure-related adverse effects | 3 months |
| Safety of endovascular treatment of CCSVI | This is defined as the number and nature of any procedure-related adverse effects | 6 months |
| Safety of endovascular treatment of CCSVI | This is defined as the number and nature of any procedure-related adverse effects | 12 months |
| Safety of endovascular treatment of CCSVI | This is defined as the number and nature of any procedure-related adverse effects | 18 months |
| Safety of endovascular treatment of CCSVI | This is defined as the number and nature of any procedure-related adverse effects | 24 months |
| Target vessel primary and secondary patency | Primary patency is the interval following the initial angioplasty procedure until a reintervention is performed to preserve patency. Secondary patency is defined as the interval following the initial angioplasty procedure until treatment of the vein is abandoned due to an inability to treat the original lesion | 3 months |
| Target vessel primary and secondary patency | Primary patency is the interval following the initial angioplasty procedure until a reintervention is performed to preserve patency. Secondary patency is defined as the interval following the initial angioplasty procedure until treatment of the vein is abandoned due to an inability to treat the original lesion | 6 months |
| Target vessel primary and secondary patency | Primary patency is the interval following the initial angioplasty procedure until a reintervention is performed to preserve patency. Secondary patency is defined as the interval following the initial angioplasty procedure until treatment of the vein is abandoned due to an inability to treat the original lesion | 12 months |
| Target vessel primary and secondary patency | Primary patency is the interval following the initial angioplasty procedure until a reintervention is performed to preserve patency. Secondary patency is defined as the interval following the initial angioplasty procedure until treatment of the vein is abandoned due to an inability to treat the original lesion | 18 months |
| Target vessel primary and secondary patency | Primary patency is the interval following the initial angioplasty procedure until a reintervention is performed to preserve patency. Secondary patency is defined as the interval following the initial angioplasty procedure until treatment of the vein is abandoned due to an inability to treat the original lesion | 24 months |
| Latham |
| New York |
| 12110 |
| United States |
| 20351674 | Background | Bartolomei I, Salvi F, Galeotti R, Salviato E, Alcanterini M, Menegatti E, Mascalchi M, Zamboni P. Hemodynamic patterns of chronic cerebrospinal venous insufficiency in multiple sclerosis. Correlation with symptoms at onset and clinical course. Int Angiol. 2010 Apr;29(2):183-8. |
| 20351673 | Background | Malagoni AM, Galeotti R, Menegatti E, Manfredini F, Basaglia N, Salvi F, Zamboni P. Is chronic fatigue the symptom of venous insufficiency associated with multiple sclerosis? A longitudinal pilot study. Int Angiol. 2010 Apr;29(2):176-82. |
| 19060024 | Background | Zamboni P, Galeotti R, Menegatti E, Malagoni AM, Tacconi G, Dall'Ara S, Bartolomei I, Salvi F. Chronic cerebrospinal venous insufficiency in patients with multiple sclerosis. J Neurol Neurosurg Psychiatry. 2009 Apr;80(4):392-9. doi: 10.1136/jnnp.2008.157164. Epub 2008 Dec 5. |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D013504 |
| Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
| D008919 | Investigative Techniques |
| D008722 | Methods |