Study To Evaluate Treating Chronic Cerebrospinal Venous Insufficiency (CCSVI) in Multiple Sclerosis Patients

• ClinicalTrials.gov Identifier: NCT01089686
• Recruitment Status: Terminated
• First Posted: March 18, 2010
• Last Update Posted: March 7, 2012
• Sponsor: Manish Mehta, MD
• Collaborator: Center for Vascular Awareness, Albany, New York
• Information provided by (Responsible Party): Manish Mehta, MD, The Vascular Group, PLLC

Study Description

Brief Summary:

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).

Condition or disease	Intervention/treatment	Phase
Multiple Sclerosis	Procedure: Venoplasty; Procedure: Sham procedure (non-treatment)	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 2 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Outcomes Assessor)
• Primary Purpose: Diagnostic
• Official Title: Utility of Chronic Cerebrospinal Venous Insufficiency Percutaneous Angioplasty for Multiple Sclerosis: The Albany Vascular Group Study (Liberation Study)
• Study Start Date: August 2010
• Estimated Primary Completion Date: October 2012
• Estimated Study Completion Date: October 2012

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Venoplasty (treatment); 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.	Procedure: Venoplasty; 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.
Sham Comparator: Sham procedure (non-treatment); 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.	Procedure: Sham procedure (non-treatment); 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.

Outcome Measures

Primary Outcome Measures :

1. Incidence of major adverse events [ Time Frame: 30 days ]
   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.
2. Neurological assessment of MS [ Time Frame: 1 year ]
   An independant neurologist will assess the number of MS attacks that have occurred during one year follow up period.
3. MRI/MRA evaluation of MS lesions, recommended [ Time Frame: 1 year ]
   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.

Secondary Outcome Measures :

1. Mortality [ Time Frame: 1 year ]
   All cause mortality will be evaluated through one year.
2. Major adverse events [ Time Frame: 1 year ]
   Incidence of all major adverse events will be collected for one year.
3. Identification of central venous stenosis [ Time Frame: 1 year ]
   Evaluation of the correlation between MRV, Duplex Ultrasound and Venogram in identifying central venous stenosis.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• Must be 18 years old or greater and less than or equal to 65 years of age
• Score of 0 to 7 on the EDSS scale
• Diagnosis of relapsing remitting or secondary progressive Multiple Sclerosis by a neurologist and confirmed by one of the independent study neurologists
• Presence of greater than or equal to 50 percent stenosis of the extracranial veins as determined by venogram
• Informed consent signed by patient

Exclusion Criteria:

• Patient is unwilling to comply with the follow up
• Patient is pregnant
• Diagnosis of primary progressive MS by a certified neurologist confirmed by one of the study neurologists
• Presence of less than 50 percent stenosis of the extracranial veins as determined by venogram
• Presence of other medical illnesses or a psychiatric condition that in the opinion of the investigator may cause the subject to be non-compliant with the protocol requirements
• Life expectancy is less than one year
• Lack of mental capacity to consent
• Creatinine level of greater than 2.5 or is dialysis dependant
• Enrollment in another clinical study

Contacts and Locations

Locations

United States, New York

The Vascular Group, PLLC, The Vascular Health Pavillion

Albany, New York, United States, 12205

Sponsors and Collaborators

Manish Mehta, MD

Center for Vascular Awareness, Albany, New York

Investigators

• Principal Investigator: Manish Mehta, MD, MPH; The Vascular Group, PLLC

More Information

Additional Information:

The Center for Vascular Awareness 

• Responsible Party: Manish Mehta, MD, Principal Investigator, The Vascular Group, PLLC
• ClinicalTrials.gov Identifier: NCT01089686
• Other Study ID Numbers: LS10-01
• First Posted: March 18, 2010
• Last Update Posted: March 7, 2012
• Last Verified: March 2012

Keywords provided by Manish Mehta, MD, The Vascular Group, PLLC:

Chronic Cerebrospinal Venous Insufficiency

Additional relevant MeSH terms:

Multiple Sclerosis; Venous Insufficiency; Sclerosis; Pathologic Processes; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Vascular Diseases; Cardiovascular Diseases