Endovascular Treatment for Chronic Cerebrospinal Venous Insufficiency (CCSVI)

NCT ID: NCT01264848

Last Updated: 2015-02-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2012-12-31

Brief Summary

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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

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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

Conditions

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Multiple Sclerosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Balloon angioplasty and/or stenting

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

Group Type EXPERIMENTAL

balloon angioplasty and/or stenting

Intervention Type PROCEDURE

balloon angioplasty and/or stenting of internal jugular veins and/or azygous vein and/or brachiocephalic veins

balloon angioplasty and/or stenting

Intervention Type PROCEDURE

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

Interventions

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balloon angioplasty and/or stenting

balloon angioplasty and/or stenting of internal jugular veins and/or azygous vein and/or brachiocephalic veins

Intervention Type 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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* patients with clinically defined multiple sclerosis

Exclusion Criteria

* contraindication for endovascular procedure performed in local anesthesia
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Euromedic Specialist Clinics, Poland

OTHER

Sponsor Role lead

Responsible Party

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Marian Simka

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marian Simka

Role: PRINCIPAL_INVESTIGATOR

Euromedic Specialist Clinics , Katowice , Poland

Locations

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Euromedic Specialist Clinics

Katowice, , Poland

Site Status

Countries

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Poland

Other Identifiers

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7/2010

Identifier Type: -

Identifier Source: org_study_id

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