Evaluation of Angioplasty in the Treatment of Chronic Cerebrospinal Venous Insufficiency (CCSVI) in Multiple Sclerosis

NCT01201707 | Terminated DMC

• 1 other identifier: 2794
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis; Angioplasty; Vein

Outcome Measures

Primary Outcomes (6)

• Impact of CCSVI treatment on quality of life in patients with MS

  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.

  1 Month

• Impact of CCSVI treatment on quality of life in patients with MS

  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.

  3 Months

• Impact of CCSVI treatment on quality of life in patients with MS

  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.

  6 Months

• Impact of CCSVI treatment on quality of life in patients with MS

  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.

  12 Months

• Impact of CCSVI treatment on quality of life in patients with MS

  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.

  18 Months

• Impact of CCSVI treatment on quality of life in patients with MS

  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.

  24 Months

Secondary Outcomes (23)

• Clinical significance of CCSVI in MS patients

  1 month

• Superiority of angioplasty to observation for treatment of CCSVI

  1 month

• Incidence of CCSVI in patients with MS

  0 Months

• Safety of endovascular treatment of CCSVI

  1 month

• Target vessel primary and secondary patency

  1 month

Study Arms (2)

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.

Procedure: Angioplasty

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.

Other: Observation

Interventions

Angioplasty PROCEDURE

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.

Treatment of CCSVI with Angioplasty

Observation OTHER

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.

Observation of CCSVI

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Community Care Physicians, P.C.: lead

Study Sites (2)

Albany Medical Center

Albany, New York, 12208, United States

Location

Image Care Latham

Latham, New York, 12110, United States

Location

Related Publications (5)

• 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. doi: 10.1016/j.jvs.2009.07.096.

  PMID: 19958985 BACKGROUND

• 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.

  PMID: 20018140 BACKGROUND

• 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.

  PMID: 20351674 BACKGROUND

• 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.

  PMID: 20351673 BACKGROUND

• 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. doi: 10.1136/jnnp.2008.157164. Epub 2008 Dec 5.

  PMID: 19060024 BACKGROUND

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Angioplasty; Observation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Catheterization; Therapeutics; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques; Methods

Study Officials

• Gary Siskin, MD

  Albany Medical College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chairman, Department of Radiology

Study Record Dates

• First Submitted: September 10, 2010
• First Posted: September 15, 2010
• Study Start: August 1, 2010
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: November 26, 2013

Record last verified: 2013-11

Locations

US (2)