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BRAVE-DREAMS (BRAin VEnous DRainage Exploited Against Multiple Sclerosis)

NCT01371760 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 212

Last updated 2015-12-17

No results posted yet for this study

Summary

To assess in a double blinded randomized control trial (RCT) study design safety and effectiveness of balloon angioplasty of the main extracranial and extravertebral veins in multiple sclerosis (MS) associated to chronic cerebrospinal venous insufficiency (CCSVI).

Mean follow-up 1 year. 5-8 Italian centres 360 relapsing remitting (RR) MS patients will be randomized, with expanded disability disease scale (EDSS) ranging 2-5.5, age 18-65.

Conditions

Interventions

PROCEDURE

Venous PTA

PTA of the internal jugular and/or azygous vein

OTHER

Catheter Venography

The patients will undergo catheter venography but not PTA

Sponsors & Collaborators

  • Regione Emilia-Romagna

    collaborator OTHER

  • S. Anna Hospital

    lead OTHER

Principal Investigators

  • Paolo Zamboni, MD · S. Anna Hospital, University of Ferrara, Ferrara, Italy

  • Graziella Filippini, MD · Istituto Neurologico Besta, Milano, Italy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2014-12-31
Completion
2015-12-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01371760 on ClinicalTrials.gov