Evaluation of Angioplasty in the Treatment of Chronic Cerebrospinal Ve
The Effectiveness of Endovascular Treatment of Chronic Cerebrospinal Venous Insufficiency (CCSVI) in Patients With Multiple Sclerosis
What it found
The trial ended early for another reason (see below).
Reason given: Inability to enroll adequate number of patients
This trial finished 13 years ago. We found no results in the registry or in any paper that cites it.
What was tested
Treatment tested
- Angioplasty
Placebo
- Observation
What it measured
Main measures
Impact of CCSVI treatment on quality of life in patients with MS
1 Month
Quality of life (reported by participants)Impact of CCSVI treatment on quality of life in patients with MS
3 Months
Quality of life (reported by participants)Impact of CCSVI treatment on quality of life in patients with MS
6 Months
Quality of life (reported by participants)Impact of CCSVI treatment on quality of life in patients with MS
12 Months
Quality of life (reported by participants)Impact of CCSVI treatment on quality of life in patients with MS
18 Months
Quality of life (reported by participants)Impact of CCSVI treatment on quality of life in patients with MS
24 Months
Quality of life (reported by participants)
Other measures (23)
Clinical significance of CCSVI in MS patients
1 month
Disability progressionRelapsesWalking and mobilitySuperiority of angioplasty to observation for treatment of CCSVI
1 month
Disability progressionRelapsesWalking and mobilityIncidence of CCSVI in patients with MS
0 Months
Safety of endovascular treatment of CCSVI
1 month
SafetyTarget vessel primary and secondary patency
1 month
MRI lesionsClinical significance of CCSVI in MS patients
6 months
Disability progressionRelapsesWalking and mobilityClinical significance of CCSVI in MS patients
12 months
Disability progressionRelapsesWalking and mobilityClinical significance of CCSVI in MS patients
18 months
Disability progressionRelapsesWalking and mobilityClinical significance of CCSVI in MS patients
24 months
Disability progressionRelapsesWalking and mobilitySuperiority of angioplasty to observation for treatment of CCSVI
6 Months
Disability progressionRelapsesWalking and mobility
Who could take part
MS (type not specified) · 18 to 60 · EDSS 3 to 6
Show the full 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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
Background
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.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.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.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.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.
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History
Started
Aug 2010
Main results due
Sept 2013
Finished
Sept 2013