Endovascular Treatment for Chronic Cerebrospinal Venous Insufficiency (CCSVI)

Phase 1

Completed

• Conditions: Multiple Sclerosis

• Registration Number: NCT01264848
• Lead Sponsor: Euromedic Specialist Clinics, Poland

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

Study Timeline

• Study Start: 2010-03
• Primary Completion: 2010-10
• Study First Submitted: 2010-12-21
• Study First Submitted QC: 2010-12-21
• Study First Posted: 2010-12-22
• Study Completion: 2012-12
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-09
• Last Update Posted: 2015-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• patients with clinically defined multiple sclerosis

Exclusion Criteria

• contraindication for endovascular procedure performed in local anesthesia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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	6 months after the procedure

Trial Locations

Locations (1)

Euromedic Specialist Clinics; 🇵🇱 Katowice, Poland