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

NCT01089686 | Terminated

• 1 other identifier: LS10-01
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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).

Conditions

Multiple Sclerosis

Keywords

Chronic Cerebrospinal Venous Insufficiency

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (3)

• Mortality

  1 year

• Major adverse events

  1 year

• Identification of central venous stenosis

  1 year

Study Arms (2)

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.

Procedure: Venoplasty

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.

Procedure: Sham procedure (non-treatment)

Interventions

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.

Venoplasty (treatment)

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.

Sham procedure (non-treatment)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Manish Mehta, MD: lead
• Center for Vascular Awareness, Albany, New York: collaborator

Study Sites (1)

The Vascular Group, PLLC, The Vascular Health Pavillion

Albany, New York, 12205, United States

Location

Related Links

• The Center for Vascular Awareness

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Manish Mehta, MD, MPH

  The Vascular Group, PLLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 17, 2010
• First Posted: March 18, 2010
• Study Start: August 1, 2010
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: March 7, 2012

Record last verified: 2012-03

Locations

US (1)