Evaluate Treating Chronic Cerebrospinal Venous Insufficiency (CCSVI) in Multiple Sclerosis Patients
Verified by The Vascular Group, PLLC, March 2010
First Received: March 17, 2010 No Changes Posted
Sponsor: The Vascular Group, PLLC
Information provided by: The Vascular Group, PLLC
ClinicalTrials.gov Identifier: NCT01089686
Purpose
The purpose of this Study is to evaluate 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.
Patients enrolled in the study will have a diagnosis of Multiple Sclerosis diagnosed according to the revised McDonald Criteria (MD) criteria, and will meet the eligibility criteria.
Condition Intervention
Multiple Sclerosis
Procedure: Angioplasty
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Utility of Chronic Cerebrospinal Venous Insufficiency Percutaneous Angioplasty for Multiple Sclerosis: The Albany Vascular Group Study (Liberation Study)
Resource links provided by NLM:
MedlinePlus related topics: Angioplasty Multiple Sclerosis
U.S. FDA Resources
Further study details as provided by The Vascular Group, PLLC:
Primary Outcome Measures:
•Incidence of major adverse events [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
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.
Secondary Outcome Measures:
•Mortality [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Secondary endpoints will be evaluated with all subjects based upon mortality, incidence of all secondary interventions and incidence of all major adverse events for a period of 2 years.
Estimated Enrollment: 500
Study Start Date: April 2010
Estimated Study Completion Date: April 2012
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Intervention Details:
Procedure: Angioplasty
To identify the presence of CCSVI, all patients will undergo a clinical evaluation by a neurologist, a duplex ultrasound of central extracranial venous system, an MRV, and a venogram. The decision to enroll patient in percutaneous angioplasty for CCSVI will be made at the time of venogram, in select patients that have greater than or equal to 50 percent stenosis of the extracranial central veins including the internal jugular veins and the azygos vein. Extracranial venous ultrasound will be performed at 3, 6, 12, 18, and 24 months following the procedure or if clinical symptoms recur. MRV and venograms will be performed at 12months and 24 months or if clinical symptoms recur.
Eligibility
Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria:
•Greater than 18 years of age
•Diagnosis of Multiple Sclerosis by a neurologist
•Presence of greater than or equal to 50 percent stenosis of the extracranial veins as determined by venogram
•Informed consent signed by patient or LAR
Exclusion Criteria:
•Patient is unwilling to comply with the follow up
•Patient is pregnant
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01089686
Contacts
Contact: Megan Wilcox, LPN 518-218-7909 wilcoxm@albanyvascular.com
Locations
United States, New York
The Vascular Group, PLLC, The Vascular Pavillion
Albany, New York, United States, 12205
Sponsors and Collaborators
The Vascular Group, PLLC
Investigators
Principal Investigator: Manish Mehta, MD, MPH The Vascular Group, PLLC
More Information
Additional Information:
The Center for Vascular Awareness
No publications provided
Responsible Party: The Vascular Group, PLLC ( Manish Mehta, MD )
Study ID Numbers: LS10-01
Study First Received: March 17, 2010
Last Updated: March 17, 2010
ClinicalTrials.gov Identifier: NCT01089686 History of Changes
Health Authority: United States: Institutional Review Board
Keywords provided by The Vascular Group, PLLC:
Chronic Cerebrospinal Venous Insufficiency
Additional relevant MeSH terms:
Pathologic Processes
Autoimmune Diseases
Multiple Sclerosis
Immune System Diseases
Demyelinating Diseases
Nervous System Diseases
Venous Insufficiency
Vascular Diseases
Demyelinating Autoimmune Diseases, CNS
Cardiovascular Diseases
Sclerosis
Autoimmune Diseases of the Nervous System
ClinicalTrials.gov processed this record on May 13, 2010
