Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NSG1730210B | Other Identifier | HSIRB - SUNY Buffalo |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Volcano Corporation | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Venous Angioplasty | Experimental | 20 patients will have venous angio plasty |
|
| Angio with no plasty | Sham Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Venous Angioplasty | Other | venous angiogram to look for lesions or flaps and then plastying vessels open. |
|
| 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. | 1 month post-procedure |
Not provided
Not provided
Inclusion Criteria:
Age 18-65 years
Constant= 1.23 for men; 1.04 for women
Exclusion Criteria:
• Relapse, disease progression and steroid treatment in the 30 days preceding study entry
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Adnan H Siddiqui, M.D., Ph. D. | University at Buffalo Neurosurgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gates Circle Hospital | Buffalo | New York | 14209 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Venous Angioplasty | Venous Angioplasty: venous angiogram to look for lesions or flaps and then plastying vessels open. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Venous Angioplasty | Venous Angioplasty: venous angiogram to look for lesions or flaps and then plastying vessels open. |
| BG001 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | 1 month post-procedure |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Venous Angioplasty | Venous Angioplasty: venous angiogram to look for lesions or flaps and then plastying vessels open. |
Not provided
| 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 |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ellen Carl | UBNS | 716-218-1000 | 7260 | ecarl@ubns.com |
Not provided
| 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 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Sham Angioplasty | Other | Patients will be brought to the angio suite and will not know if they are having the venous angioplasty or not. |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
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.
|
|
| 0 |
| 9 |
| 3 |
| 9 |
| EG001 | 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. | 0 | 10 | 3 | 10 |
|
| 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 |
|
Not provided
Not provided
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |