Endovascular Treatment for Chronic Cerebrospinal Venous Insufficiency (CCSVI)
Phase 1
Completed
- Conditions
- Multiple Sclerosis
- Interventions
- Procedure: balloon angioplasty and/or stenting
- 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
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
- Arm && Interventions
Group Intervention Description Balloon angioplasty and/or stenting balloon angioplasty and/or stenting Balloon angioplasty and/or stenting of stenosed internal jugular vein and/or azygous vein and/or brachiocephalic vein
- 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Euromedic Specialist Clinics
🇵🇱Katowice, Poland