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

Primary Purpose

Multiple Sclerosis

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Venoplasty
Sham procedure (non-treatment)
Sponsored by
Manish Mehta, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Multiple Sclerosis focused on measuring Chronic Cerebrospinal Venous Insufficiency

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • The Vascular Group, PLLC, The Vascular Health Pavillion

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Venoplasty (treatment)

Sham procedure (non-treatment)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
Neurological assessment of MS
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
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
All cause mortality will be evaluated through one year.
Major adverse events
Incidence of all major adverse events will be collected for one year.
Identification of central venous stenosis
Evaluation of the correlation between MRV, Duplex Ultrasound and Venogram in identifying central venous stenosis.

Full Information

First Posted
March 17, 2010
Last Updated
March 6, 2012
Sponsor
Manish Mehta, MD
Collaborators
Center for Vascular Awareness, Albany, New York
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1. Study Identification

Unique Protocol Identification Number
NCT01089686
Brief Title
Study To Evaluate Treating Chronic Cerebrospinal Venous Insufficiency (CCSVI) in Multiple Sclerosis Patients
Official Title
Utility of Chronic Cerebrospinal Venous Insufficiency Percutaneous Angioplasty for Multiple Sclerosis: The Albany Vascular Group Study (Liberation Study)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Terminated
Study Start Date
August 2010 (undefined)
Primary Completion Date
October 2012 (Anticipated)
Study Completion Date
October 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Manish Mehta, MD
Collaborators
Center for Vascular Awareness, Albany, New York

4. Oversight

Data Monitoring Committee
No

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Chronic Cerebrospinal Venous Insufficiency

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Venoplasty (treatment)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Sham procedure (non-treatment)
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Venoplasty
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Sham procedure (non-treatment)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incidence of major adverse events
Description
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.
Time Frame
30 days
Title
Neurological assessment of MS
Description
An independant neurologist will assess the number of MS attacks that have occurred during one year follow up period.
Time Frame
1 year
Title
MRI/MRA evaluation of MS lesions, recommended
Description
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.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Mortality
Description
All cause mortality will be evaluated through one year.
Time Frame
1 year
Title
Major adverse events
Description
Incidence of all major adverse events will be collected for one year.
Time Frame
1 year
Title
Identification of central venous stenosis
Description
Evaluation of the correlation between MRV, Duplex Ultrasound and Venogram in identifying central venous stenosis.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manish Mehta, MD, MPH
Organizational Affiliation
The Vascular Group, PLLC
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Vascular Group, PLLC, The Vascular Health Pavillion
City
Albany
State/Province
New York
ZIP/Postal Code
12205
Country
United States

12. IPD Sharing Statement

Links:
URL
http://vaware.org
Description
The Center for Vascular Awareness

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

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