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

Multiple Sclerosis Clinical Trial

Official title:

Utility of Chronic Cerebrospinal Venous Insufficiency Percutaneous Angioplasty for Multiple Sclerosis: The Albany Vascular Group Study (Liberation Study)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01089686
• Other study ID #: LS10-01
• Status: Terminated
• Phase: N/A
• First received: March 17, 2010
• Last updated: March 6, 2012
• Start date: August 2010
• Est. completion date: October 2012

Study information

• Verified date: March 2012
• Source: The Vascular Group, PLLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis
• Venous Insufficiency

Intervention

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 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.

Locations

Country	Name	City	State
United States	The Vascular Group, PLLC, The Vascular Health Pavillion	Albany	New York

Sponsors (2)

Lead Sponsor	Collaborator
Manish Mehta, MD	Center for Vascular Awareness, Albany, New York

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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	No
Primary	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	No
Secondary	Mortality	All cause mortality will be evaluated through one year.	1 year	Yes
Secondary	Major adverse events	Incidence of all major adverse events will be collected for one year.	1 year	Yes
Secondary	Identification of central venous stenosis	Evaluation of the correlation between MRV, Duplex Ultrasound and Venogram in identifying central venous stenosis.	1 year	No

External Links

•   The Center for Vascular Awareness