Study To Evaluate Treating Chronic Cerebrospinal Venous Insufficiency (CCSVI) in Multiple Sclerosis Patients - Full Text View

Sponsor:	Manish Mehta, MD
Collaborator:	Center for Vascular Awareness, Albany, New York
Information provided by (Responsible Party):	Manish Mehta, MD, The Vascular Group, PLLC
ClinicalTrials.gov Identifier:	NCT01089686

Purpose

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	Intervention
Multiple Sclerosis	Procedure: Venoplasty Procedure: Sham procedure (non-treatment)

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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)

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.
Neurological assessment of MS [ Time Frame: 1 year ] [ Designated as safety issue: No ]
An independant neurologist will assess the number of MS attacks that have occurred during one year follow up period.
MRI/MRA evaluation of MS lesions, recommended [ Time Frame: 1 year ] [ Designated as safety issue: No ]
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:

Mortality [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
All cause mortality will be evaluated through one year.
Major adverse events [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Incidence of all major adverse events will be collected for one year.
Identification of central venous stenosis [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Evaluation of the correlation between MRV, Duplex Ultrasound and Venogram in identifying central venous stenosis.

Estimated Enrollment:	600
Study Start Date:	August 2010
Estimated Study Completion Date:	October 2012
Estimated Primary Completion Date:	October 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

Arms

Assigned Interventions

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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT01089686

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 This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Manish Mehta, MD, Principal Investigator, The Vascular Group, PLLC
ClinicalTrials.gov Identifier:	NCT01089686 History of Changes
Other Study ID Numbers:	LS10-01
Study First Received:	March 17, 2010
Last Updated:	November 15, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by The Vascular Group, PLLC:

Chronic Cerebrospinal Venous Insufficiency

Additional relevant MeSH terms:

Multiple Sclerosis
Sclerosis
Venous Insufficiency
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases

Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on February 09, 2012