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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control arm | Sham Comparator | Venography and sham angioplasty |
|
| Active arm | Active Comparator | therapeutic balloon angioplasty |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Selective Venography followed by therapeutic balloon angioplasty | Device | Venography followed by therapeutic balloon angioplasty |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 24 hours-1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With More Than 75% of Normal Outflow at 1 Year Post-angioplasty | Restoration of venous outflow (more than 75% of normal outflow) as measured by the combined ECD/TCD and MRV at 1 year following the angioplasty as compared to baseline as well as compared to a parallel control group of MS patients that will undergo only selective venography without balloon angioplasty (sham-angioplasty). These comparisons will be accomplished by the hierarchical linear model which takes into account the correlation within subjects. Based on the residuals, we will check the normality assumptions by the normal quantile plot and skewness. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Adnan Siddiqui, MD, PhD | University at Buffalo Neurosurgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University at Buffalo Neurosurgery | Buffalo | New York | 14209 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24975855 | Derived | Siddiqui AH, Zivadinov R, Benedict RH, Karmon Y, Yu J, Hartney ML, Marr KL, Valnarov V, Kennedy CL, Ramanathan M, Ramasamy DP, Dolic K, Hojnacki DW, Carl E, Levy EI, Hopkins LN, Weinstock-Guttman B. Prospective randomized trial of venous angioplasty in MS (PREMiSe). Neurology. 2014 Jul 29;83(5):441-9. doi: 10.1212/WNL.0000000000000638. Epub 2014 Jun 27. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Venography & Sham Angioplasty | Venography and sham angioplasty Control arm: Venography and sham angioplasty |
| FG001 | Therapeutic Balloon Angioplasty | therapeutic balloon angioplasty Selective Venography followed by therapeutic balloon angioplasty: Venography followed by therapeutic balloon angioplasty |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control Arm | Venography and sham angioplasty Control arm: Venography and sham angioplasty |
| BG001 | Active Arm | therapeutic balloon angioplasty Selective Venography followed by therapeutic balloon angioplasty: Venography followed by therapeutic balloon angioplasty |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | 24 hours-1 month |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control Arm | Venography and sham angioplasty Control arm: Venography and sham angioplasty |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Immune thrombocytopenic purpura | Immune system disorders | Systematic Assessment | Immune thrombocytopenic purpura treated with 100mg prednisone once daily |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ellen Carl | UBNS | 716-218-1000 | 7260 | ecarl@ubns.com |
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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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| Control arm | Other | Venography and sham angioplasty |
|
| 1 month, 3 months, 6 months, and 1 year post-angioplasty |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Number of Participants With More Than 75% of Normal Outflow at 1 Year Post-angioplasty | Restoration of venous outflow (more than 75% of normal outflow) as measured by the combined ECD/TCD and MRV at 1 year following the angioplasty as compared to baseline as well as compared to a parallel control group of MS patients that will undergo only selective venography without balloon angioplasty (sham-angioplasty). These comparisons will be accomplished by the hierarchical linear model which takes into account the correlation within subjects. Based on the residuals, we will check the normality assumptions by the normal quantile plot and skewness. | Posted | Count of Participants | Participants | 1 month, 3 months, 6 months, and 1 year post-angioplasty |
|
|
|
| 0 |
| 10 |
| 3 |
| 10 |
| EG001 | Active Arm | therapeutic balloon angioplasty Selective Venography followed by therapeutic balloon angioplasty: Venography followed by therapeutic balloon angioplasty | 0 | 9 | 3 | 9 |
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| Bladder infection | Renal and urinary disorders | Systematic Assessment | Bladder infection treated with antibiotics over 10 days |
|
| Shingles | Nervous system disorders | Systematic Assessment | Diagnosis of shingles treated with Valtrex (GlaxoSmithKline) 3x daily for 7 days |
|
| Cardiac event | Cardiac disorders | Systematic Assessment | Cardiac event treated with pacemaker installation |
|
| Swelling & Soreness | General disorders | Systematic Assessment | Swelling and soreness at left side of the neck; no treatment required |
|
| Transobturator sling | Renal and urinary disorders | Systematic Assessment | Hospitalization for scheduled transobturator sling procedure |
|
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| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |