Endovascular Treatment for Chronic Cerebrospinal Venous Insufficiency (CCSVI)
Primary Purpose
Multiple Sclerosis
Status
Completed
Phase
Phase 1
Locations
Poland
Study Type
Interventional
Intervention
balloon angioplasty and/or stenting
balloon angioplasty and/or stenting
Sponsored by
About this trial
This is an interventional supportive care trial for Multiple Sclerosis focused on measuring multiple sclerosis, venous insufficiency
Eligibility Criteria
Inclusion Criteria:
- patients with clinically defined multiple sclerosis
Exclusion Criteria:
- contraindication for endovascular procedure performed in local anesthesia
Sites / Locations
- Euromedic Specialist Clinics
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Balloon angioplasty and/or stenting
Arm Description
Balloon angioplasty and/or stenting of stenosed internal jugular vein and/or azygous vein and/or brachiocephalic vein
Outcomes
Primary Outcome Measures
Change in clinical symptoms of multiple sclerosis measured by Extended Disability Severity Score (EDSS), Multiple Sclerosis Impact Scale-29 (MSIS-29), Fatigue Severity Scale (FSS) and heat intolerance
Secondary Outcome Measures
Full Information
NCT ID
NCT01264848
First Posted
December 21, 2010
Last Updated
February 9, 2015
Sponsor
Euromedic Specialist Clinics, Poland
1. Study Identification
Unique Protocol Identification Number
NCT01264848
Brief Title
Endovascular Treatment for Chronic Cerebrospinal Venous Insufficiency (CCSVI)
Official Title
Endovascular Correction of Chronic Cerebrospinal Venous Insufficiency (CCSVI) and Evaluation of Influence of These Treatments on the Symptoms of Multiple Sclerosis
Study Type
Interventional
2. Study Status
Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Euromedic Specialist Clinics, Poland
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of this study is to assess the efficacy of endovascular treatment (balloon angioplasty and/or stenting) for the improvement of clinical symptoms in multiple sclerosis patients.
Detailed Description
The aim of this study is to assess the efficacy of endovascular treatment (balloon angioplasty and/or stenting) for the improvement of clinical symptoms in multiple sclerosis patients measured by Extended Disability Severity Score (EDSS), Multiple Sclerosis Impact Scale-29 (MSIS-29), Fatigue Severity Scale (FSS) and heat intolerance
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
multiple sclerosis, venous insufficiency
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Balloon angioplasty and/or stenting
Arm Type
Experimental
Arm Description
Balloon angioplasty and/or stenting of stenosed internal jugular vein and/or azygous vein and/or brachiocephalic vein
Intervention Type
Procedure
Intervention Name(s)
balloon angioplasty and/or stenting
Intervention Description
balloon angioplasty and/or stenting of internal jugular veins and/or azygous vein and/or brachiocephalic veins
Intervention Type
Procedure
Intervention Name(s)
balloon angioplasty and/or stenting
Intervention Description
balloon angioplasty and/or stenting of extracranial vein draining the central nervous system, on condition that such outflow pathology has been confirmed using catheter venography
Primary Outcome Measure Information:
Title
Change in clinical symptoms of multiple sclerosis measured by Extended Disability Severity Score (EDSS), Multiple Sclerosis Impact Scale-29 (MSIS-29), Fatigue Severity Scale (FSS) and heat intolerance
Time Frame
6 months after the procedure
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients with clinically defined multiple sclerosis
Exclusion Criteria:
contraindication for endovascular procedure performed in local anesthesia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marian Simka
Organizational Affiliation
Euromedic Specialist Clinics , Katowice , Poland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Euromedic Specialist Clinics
City
Katowice
Country
Poland
12. IPD Sharing Statement
Learn more about this trial
Endovascular Treatment for Chronic Cerebrospinal Venous Insufficiency (CCSVI)
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