Clinical Trials --- Evaluation of Angioplasty in the Treatment of Chronic Cerebrospinal Venous Insufficiency (CCSVI) in Multiple Sclerosis - facebook prikbord

This study is currently recruiting participants.

Verified by Community Care Physicians, P.C., September 2010

First Received: September 10, 2010 Last Updated: September 20, 2010 History of Changes

Sponsor:	Community Care Physicians, P.C.
Information provided by:	Community Care Physicians, P.C.
ClinicalTrials.gov Identifier:	NCT01201707

Purpose

The study is being done to determine if venous angioplasty is an effective treatment for chronic cerebrospinal venous insufficiency (CCSVI). In this condition, areas of narrowing or blockages are present in the internal jugular or azygos veins (veins which drain blood from the central nervous system) and these blockages may be associated with symptoms classically attributed to MS. Therefore, angioplasty may help to improve the symptoms associated with CCSVI and multiple sclerosis (MS). In this study, the investigators will evaluate the effectiveness of angioplasty in the treatment of CCSVI by comparing two the outcomes of two groups of patients: one group with CCSVI diagnosed on a venogram and treated with angioplasty and one group with CCSVI diagnosed on a venogram but not treated. The patients enrolled in this study, and the neurologist evaluating patients after the procedure, will not know whether or not they were treated with angioplasty.

Condition	Intervention
Multiple Sclerosis	Procedure: Angioplasty Other: Observation

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	The Effectiveness of Endovascular Treatment of Chronic Cerebrospinal Venous Insufficiency (CCSVI) in Patients With Multiple Sclerosis

Resource links provided by NLM:

MedlinePlus related topics: Angioplasty Multiple Sclerosis

U.S. FDA Resources

Further study details as provided by Community Care Physicians, P.C.:

Primary Outcome Measures:

Impact of CCSVI treatment on quality of life in patients with MS [ Time Frame: 1 Month ] [ Designated as safety issue: No ]
This will be assessed using the Multiple Sclerosis Quality of Life-54 (MSQOL-54), which is a health-related quality of life measure that combines generic and MS-specific items into a single, self-report questionnaire.

Impact of CCSVI treatment on quality of life in patients with MS [ Time Frame: 3 Months ] [ Designated as safety issue: No ]
This will be assessed using the Multiple Sclerosis Quality of Life-54 (MSQOL-54), which is a health-related quality of life measure that combines generic and MS-specific items into a single, self-report questionnaire.

Impact of CCSVI treatment on quality of life in patients with MS [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
This will be assessed using the Multiple Sclerosis Quality of Life-54 (MSQOL-54), which is a health-related quality of life measure that combines generic and MS-specific items into a single, self-report questionnaire.

Impact of CCSVI treatment on quality of life in patients with MS [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
This will be assessed using the Multiple Sclerosis Quality of Life-54 (MSQOL-54), which is a health-related quality of life measure that combines generic and MS-specific items into a single, self-report questionnaire.

Impact of CCSVI treatment on quality of life in patients with MS [ Time Frame: 18 Months ] [ Designated as safety issue: No ]
This will be assessed using the Multiple Sclerosis Quality of Life-54 (MSQOL-54), which is a health-related quality of life measure that combines generic and MS-specific items into a single, self-report questionnaire.

Impact of CCSVI treatment on quality of life in patients with MS [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
This will be assessed using the Multiple Sclerosis Quality of Life-54 (MSQOL-54), which is a health-related quality of life measure that combines generic and MS-specific items into a single, self-report questionnaire.

Secondary Outcome Measures:

Clinical significance of CCSVI in MS patients [ Time Frame: 1 month ] [ Designated as safety issue: No ]
This will be assessed clinically using annualized relapse rates, Expanded Disability Status Scale (EDSS) change and change in the timed 25 foot walk.

Superiority of angioplasty to observation for treatment of CCSVI [ Time Frame: 1 month ] [ Designated as safety issue: No ]
This will be assessed clinically using annualized relapse rates, EDSS change, and change in the timed 25-foot walk

Incidence of CCSVI in patients with MS [ Time Frame: 0 Months ] [ Designated as safety issue: No ]
This will be assessed on the basis of the findings on diagnostic venography of the internal jugular and azygos veins, which is the initial procedure performed in these patients.

Safety of endovascular treatment of CCSVI [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
This is defined as the number and nature of any procedure-related adverse effects

Target vessel primary and secondary patency [ Time Frame: 1 month ] [ Designated as safety issue: No ]
Primary patency is the interval following the initial angioplasty procedure until a reintervention is performed to preserve patency. Secondary patency is defined as the interval following the initial angioplasty procedure until treatment of the vein is abandoned due to an inability to treat the original lesion

Clinical significance of CCSVI in MS patients [ Time Frame: 6 months ] [ Designated as safety issue: No ]
This will be assessed clinically using annualized relapse rates, EDSS change and change in the timed 25 foot walk.

Clinical significance of CCSVI in MS patients [ Time Frame: 12 months ] [ Designated as safety issue: No ]
This will be assessed clinically using annualized relapse rates, EDSS change and change in the timed 25 foot walk.

Clinical significance of CCSVI in MS patients [ Time Frame: 18 months ] [ Designated as safety issue: No ]
This will be assessed clinically using annualized relapse rates, EDSS change and change in the timed 25 foot walk.

Clinical significance of CCSVI in MS patients [ Time Frame: 24 months ] [ Designated as safety issue: No ]
This will be assessed clinically using annualized relapse rates, EDSS change and change in the timed 25 foot walk.

Superiority of angioplasty to observation for treatment of CCSVI [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
This will be assessed clinically using annualized relapse rates, EDSS change, and change in the timed 25-foot walk

Superiority of angioplasty to observation for treatment of CCSVI [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
This will be assessed clinically using annualized relapse rates, EDSS change, and change in the timed 25-foot walk

Superiority of angioplasty to observation for treatment of CCSVI [ Time Frame: 18 Months ] [ Designated as safety issue: No ]
This will be assessed clinically using annualized relapse rates, EDSS change, and change in the timed 25-foot walk

Superiority of angioplasty to observation for treatment of CCSVI [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
This will be assessed clinically using annualized relapse rates, EDSS change, and change in the timed 25-foot walk

Safety of endovascular treatment of CCSVI [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
This is defined as the number and nature of any procedure-related adverse effects

Safety of endovascular treatment of CCSVI [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
This is defined as the number and nature of any procedure-related adverse effects

Safety of endovascular treatment of CCSVI [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
This is defined as the number and nature of any procedure-related adverse effects

Safety of endovascular treatment of CCSVI [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
This is defined as the number and nature of any procedure-related adverse effects

Safety of endovascular treatment of CCSVI [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
This is defined as the number and nature of any procedure-related adverse effects

Target vessel primary and secondary patency [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Primary patency is the interval following the initial angioplasty procedure until a reintervention is performed to preserve patency. Secondary patency is defined as the interval following the initial angioplasty procedure until treatment of the vein is abandoned due to an inability to treat the original lesion

Target vessel primary and secondary patency [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Primary patency is the interval following the initial angioplasty procedure until a reintervention is performed to preserve patency. Secondary patency is defined as the interval following the initial angioplasty procedure until treatment of the vein is abandoned due to an inability to treat the original lesion

Target vessel primary and secondary patency [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Primary patency is the interval following the initial angioplasty procedure until a reintervention is performed to preserve patency. Secondary patency is defined as the interval following the initial angioplasty procedure until treatment of the vein is abandoned due to an inability to treat the original lesion

Target vessel primary and secondary patency [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Primary patency is the interval following the initial angioplasty procedure until a reintervention is performed to preserve patency. Secondary patency is defined as the interval following the initial angioplasty procedure until treatment of the vein is abandoned due to an inability to treat the original lesion

Target vessel primary and secondary patency [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Primary patency is the interval following the initial angioplasty procedure until a reintervention is performed to preserve patency. Secondary patency is defined as the interval following the initial angioplasty procedure until treatment of the vein is abandoned due to an inability to treat the original lesion

Estimated Enrollment:	130
Study Start Date:	August 2010
Estimated Study Completion Date:	August 2013
Estimated Primary Completion Date:	August 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Treatment of CCSVI with Angioplasty: Experimental At the time of venography, these patients will have had a significant lesion (blockage) in the internal jugular and/or the azygos vein that will be treated with angioplasty. Intervention: Procedure: Angioplasty	Procedure: Angioplasty In this procedure, a small catheter (tube) that is approximately the size of a piece of spaghetti is introduced into the vein that is narrowed based on the findings of the venogram. This catheter has a small balloon on it. That balloon is inflated across the narrowing within the vein with the goal of increasing the diameter of that vein and improving flow within that vein.
Observation of CCSVI: Sham Comparator At the time of venography, these patients will have had a significant lesion (blockage) in the internal jugular and/or the azygos vein that will not be treated with angioplasty. These patients will be observed after treatment and compared to those patients who received treatment. Intervention: Other: Observation	Other: Observation Patients in this arm will be diagnosed with CCSVI based on venography but will receive no intervention. They will be followed in the same manner as patients treated with angioplasty.

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients who are willing to comply with the protocol requirements and can be contacted by telephone

Patients 18-60 years of age

Patients with clinically definite multiple sclerosis by Polman criteria

Patients with a history of MS as defined above with an EDSS between 3-6.

Patients with a significant stenosis of the internal jugular or azygos vein on the basis of magnetic resonance venography or Doppler ultrasound.

Exclusion Criteria:

Patients with renal insufficiency based on an estimated GFR <45

Patients with a known severe allergy to iodine or gadolinium-based contrast agents which cannot be adequately pre-medicated

Patients with a known allergy to nickel

Patients who pregnant

Patients with a contraindication to anticoagulation or anti-platelet medication

Patients with a contraindication to drugs used for conscious sedation during interventional procedures, including Versed and Fentanyl

Patients with a history of deep venous thrombosis of the lower extremities

Patients with occlusion of the right and left common femoral veins

Patients who have had any changes in their disease modifying drug regimen for MS during the 6 months prior to enrollment in this trial. This would include the addition of any new medications, a change in the dosage of any medications, or the removal of any medications from a patient's drug regimen

Patients with a life expectancy <18 months

Patients who are currently enrolled or who plan to enroll in other investigations that conflict with follow-up testing or confounds data in this trial

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01201707

Contacts

Contact: Barbara MacDowell	518-262-5356	macdowb@mail.amc.edu
Contact: Katy Regan	518-262-5938	regank@mail.amc.edu

Locations

United States, New York
Albany Medical Center	Recruiting
Albany, New York, United States, 12208
Contact: Barbara MacDowell 518-262-5356 macdowb@mail.amc.edu
Principal Investigator: Gary P Siskin, MD
Sub-Investigator: Krupa Pandey, MD
Sub-Investigator: John Dalfino, MD
Sub-Investigator: Kenneth Mandato, MD
Image Care Latham	Recruiting
Latham, New York, United States, 12110
Contact: Barbara MacDowell 518-262-5356 macdowb@mail.amc.edu

Sponsors and Collaborators

Community Care Physicians, P.C.

Investigators

Principal Investigator:

Gary Siskin, MD

Albany Medical College

More Information
Additional Information:

Practice website with educational materials regarding CCSVI This link exits the ClinicalTrials.gov site

Publications:

Zamboni P, Galeotti R, Menegatti E, Malagoni AM, Gianesini S, Bartolomei I, Mascoli F, Salvi F. A prospective open-label study of endovascular treatment of chronic cerebrospinal venous insufficiency. J Vasc Surg. 2009 Dec;50(6):1348-58.e1-3. Erratum in: J Vasc Surg. 2010 Apr;51(4):1079.

Zamboni P, Menegatti E, Weinstock-Guttman B, Schirda C, Cox JL, Malagoni AM, Hojanacki D, Kennedy C, Carl E, Dwyer MG, Bergsland N, Galeotti R, Hussein S, Bartolomei I, Salvi F, Zivadinov R. The severity of chronic cerebrospinal venous insufficiency in patients with multiple sclerosis is related to altered cerebrospinal fluid dynamics. Funct Neurol. 2009 Jul-Sep;24(3):133-8.

Bartolomei I, Salvi F, Galeotti R, Salviato E, Alcanterini M, Menegatti E, Mascalchi M, Zamboni P. Hemodynamic patterns of chronic cerebrospinal venous insufficiency in multiple sclerosis. Correlation with symptoms at onset and clinical course. Int Angiol. 2010 Apr;29(2):183-8.

Malagoni AM, Galeotti R, Menegatti E, Manfredini F, Basaglia N, Salvi F, Zamboni P. Is chronic fatigue the symptom of venous insufficiency associated with multiple sclerosis? A longitudinal pilot study. Int Angiol. 2010 Apr;29(2):176-82.

Zamboni P, Galeotti R, Menegatti E, Malagoni AM, Tacconi G, Dall'Ara S, Bartolomei I, Salvi F. Chronic cerebrospinal venous insufficiency in patients with multiple sclerosis. J Neurol Neurosurg Psychiatry. 2009 Apr;80(4):392-9. Epub 2008 Dec 5.

Responsible Party:	Albany Medical Center ( Gary Siskin, MD; Professor and Chairman Department of Radiology )
ClinicalTrials.gov Identifier:	NCT01201707 History of Changes
Other Study ID Numbers:	2794
Study First Received:	September 10, 2010
Last Updated:	September 20, 2010
Health Authority:	United States: Institutional Review Board

Keywords provided by Community Care Physicians, P.C.:

Multiple Sclerosis
Angioplasty
Vein

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 10, 2011

http://clinicaltrials.gov/ct2/show/NCT01201707?term=ccsvi&rank=2