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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: February 9, 2015
Last verified: February 2015
  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:


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 ]

Enrollment: 100
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

Ages Eligible for Study:   Child, Adult, Senior
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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: February 9, 2015
Health Authority: Poland: Ethics Committee

Keywords provided by 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

ClinicalTrials.gov processed this record on September 27, 2016