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| Name | Class |
|---|---|
| Center for Vascular Awareness, Albany, New York | OTHER |
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This is a single center, multispecialty, randomized double blind placebo control feasibility clinical trial. The purpose is to evaluate the safety, feasibility and efficacy of percutaneous transluminal angioplasty in treating extracranial venous obstructive lesions, and its influence on the clinical outcomes of Multiple Sclerosis (MS) patients that have been found to have chronic cerebrospinal venous insufficiency (CCSVI).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Venoplasty (treatment) | Active Comparator | Patients will be randomized to treatment or non-treatment arm with a 2:1 ratio. Patients who meet the inclusion/exclusion criteria and who are randomized to the treatment arm of the study will receive venoplasty at the time of the diagnostic venogram. |
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| Sham procedure (non-treatment) | Sham Comparator | Patients will be randomized to treatment or non-treatment with a 2:1 ratio. Patients who meet the inclusion/exclusion criteria and who are randomized to the non-treatment arm of the study will receive the diagnostic venogram only. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Venoplasty | Procedure | Venous access is obtained from the groin through the femoral vein. The catheter will be advanced into the veins in the neck and chest. Angiographic images will be taken of the extracranial venous system as well as the azygous vein. These images will be used to confirm CCSVI. Venoplasty is performed by inserting an additional catheter with a balloon at the tip. The balloon will be inflated to open the vessel. Once dilation of the vessel is confirmed, the venous sheath will be removed and manual compression applied to the groin access. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of major adverse events | The evaluation of safety will be defined as the incidence of major adverse events at 30 days following the index procedure. The evaluation of feasibility and efficacy will be determined by those patients that do not have more than 50 percent restenosis within the 30 day time frame. | 30 days |
| Neurological assessment of MS | An independant neurologist will assess the number of MS attacks that have occurred during one year follow up period. | 1 year |
| MRI/MRA evaluation of MS lesions, recommended | Evaluation of imaging to reveal local iron content, change in MS lesions and oxygen saturation changes using conventional MRA/MRI methods by an independant radiologist. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | All cause mortality will be evaluated through one year. | 1 year |
| Major adverse events | Incidence of all major adverse events will be collected for one year. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Manish Mehta, MD, MPH | The Vascular Group, PLLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Vascular Group, PLLC, The Vascular Health Pavillion | Albany | New York | 12205 | United States |
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| Label | URL |
|---|---|
| The Center for Vascular Awareness | View source |
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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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| Sham procedure (non-treatment) | Procedure | Venous access is obtained from the groin through the femoral vein. The catheter will be advanced into the veins in the neck and chest. Angiographic images will be taken of the extracranial venous system as well as the azygous vein. These images will be used to confirm CCSVI. Since the patient has been randomized to the non-treatment arm of the trial, the procedure will end without venoplasty. After completion of the diagnostic venogram, the venous sheath will be removed and manual compression applied to the groin access. |
|
| 1 year |
| Identification of central venous stenosis | Evaluation of the correlation between MRV, Duplex Ultrasound and Venogram in identifying central venous stenosis. | 1 year |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |