Endovascular Treatment for Chronic Cerebrospinal Venous Insufficiency (CCSVI)

Euromedic Specialist Clinics, Poland

Status and phase: Completed; Phase 2; Phase 1

Conditions: Multiple Sclerosis

Treatments: Procedure: balloon angioplasty and/or stenting

Study type: Interventional

Funder types: Other

Identifiers

NCT01264848

7/2010

Details and patient eligibility

About

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.

Full 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

Enrollment: 100 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients with clinically defined multiple sclerosis

Exclusion criteria

• contraindication for endovascular procedure performed in local anesthesia

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Balloon angioplasty and/or stenting

Experimental group

Description:

Balloon angioplasty and/or stenting of stenosed internal jugular vein and/or azygous vein and/or brachiocephalic vein

Treatment:

Procedure: balloon angioplasty and/or stenting

Procedure: balloon angioplasty and/or stenting