Endovascular Treatment for Chronic Cerebrospinal Venous Insufficiency (CCSVI)
This study is ongoing, but not recruiting participants.
Sponsor:
Euromedic Specialist Clinics, Poland
Information provided by:
Euromedic Specialist Clinics, Poland
ClinicalTrials.gov Identifier:
NCT01264848
First received: December 21, 2010
Last updated: August 28, 2011
Last verified: August 2011
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Purpose
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.
Condition | Intervention | Phase |
---|---|---|
Multiple Sclerosis |
Procedure: balloon angioplasty and/or stenting |
Phase 1 Phase 2 |
Study Type: | Interventional |
Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Supportive Care |
Official Title: | Endovascular Correction of Chronic Cerebrospinal Venous Insufficiency (CCSVI) and Evaluation of Influence of These Treatments on the Symptoms of Multiple Sclerosis |
Resource links provided by NLM:
Further study details as provided by Euromedic Specialist Clinics, Poland:
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 [ Time Frame: 6 months after the procedure ] [ Designated as safety issue: Yes ]
Estimated Enrollment: | 1000 |
Study Start Date: | March 2010 |
Estimated Study Completion Date: | October 2011 |
Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Experimental: Balloon angioplasty and/or stenting
Balloon angioplasty and/or stenting of stenosed internal jugular vein and/or azygous vein and/or brachiocephalic vein
|
Procedure: balloon angioplasty and/or stenting
balloon angioplasty and/or stenting of internal jugular veins and/or azygous vein and/or brachiocephalic veins
Procedure: balloon angioplasty and/or stenting
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
|
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
Eligibility
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- patients with clinically defined multiple sclerosis
Exclusion Criteria:
- contraindication for endovascular procedure performed in local anesthesia
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01264848
Locations
Poland | |
Euromedic Specialist Clinics | |
Katowice, Poland |
Sponsors and Collaborators
Euromedic Specialist Clinics, Poland
Investigators
Principal Investigator: | Marian Simka | Euromedic Specialist Clinics , Katowice , Poland |
More Information
No publications provided
Keywords provided by Euromedic Specialist Clinics, Poland:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 18, 2012
No publications provided
Responsible Party: | principal investigator: Marian Simka, Euromedic Specialist Clinics, Poland |
ClinicalTrials.gov Identifier: | NCT01264848 History of Changes |
Other Study ID Numbers: | 7/2010 |
Study First Received: | December 21, 2010 |
Last Updated: | August 28, 2011 |
Health Authority: | Poland: Ethics Committee |
Keywords provided by Euromedic Specialist Clinics, Poland:
multiple sclerosis venous insufficiency |
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 October 18, 2012