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Endovascular Treatment for Chronic Cerebrospinal Venous Insufficiency (CCSVI)

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ClinicalTrials.gov Identifier: NCT01264848
Recruitment Status : Completed
First Posted : December 22, 2010
Last Update Posted : February 10, 2015
Sponsor:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Procedure: balloon angioplasty and/or stenting Phase 1 Phase 2

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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : March 2010
Primary Completion Date : October 2010
Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Marian Simka, PhD, Euromedic Specialist Clinics, Poland
ClinicalTrials.gov Identifier: NCT01264848     History of Changes
Other Study ID Numbers: 7/2010
First Posted: December 22, 2010    Key Record Dates
Last Update Posted: February 10, 2015
Last Verified: February 2015

Keywords provided by Marian Simka, Euromedic Specialist Clinics, Poland:
multiple sclerosis
venous insufficiency

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Venous Insufficiency
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Vascular Diseases
Cardiovascular Diseases