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Endovascular Treatment for Chronic Cerebrospinal Venous Insufficiency (CCSVI)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Marian Simka, Euromedic Specialist Clinics, Poland
ClinicalTrials.gov Identifier:
NCT01264848
First received: December 21, 2010
Last updated: January 30, 2013
Last verified: January 2013
History of Changes
  Purpose

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:

U.S. FDA Resources

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
Study Completion Date: December 2012
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

Responsible Party: Marian Simka, PhD, 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: January 30, 2013
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 May 16, 2013