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Multi-center Registry for CCSVI Testing and Treatment

NCT ID: NCT01205633

Last Updated: 2012-09-18

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

SUSPENDED

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-09-30

Study Completion Date

2015-09-30

Brief Summary

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Patients suspected of CCSVI (chronic cerebrospinal venous insufficiency) may be tested and if appropriate treated with catheter venoplasty by an interventional radiologist in their local community who has been credentialled either by the local hospital's IRB or a national IRB if the procedure is done in an outpatient facility. Catheter angioplasty is a long-established and accepted medical procedure, patients' insurance should but may not cover the testing or treatment.

Detailed Description

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more to follow

Conditions

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CCSVI Chronic Cerebrospinal Venous Insufficiency Venous Malformations of CNS Draining Veins

Keywords

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neurodegenerative disease neurovascular disease fatigue Hubbard Foundation angioplasty

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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CNS draining vein abnormalities

venous angioplasty

Intervention Type PROCEDURE

catheter venous angioplasty via femoral vein approach

Interventions

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venous angioplasty

catheter venous angioplasty via femoral vein approach

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

Referral by patients primary treating physician for suspected CCSVI

Exclusion Criteria

Abnormal kidney function Allergy to either or both of the imaging contrast agents Pacemaker or other implantable device Ferrous metal in or on the body Claustrophobia Pregnancy

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Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hubbard Foundation

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David R Hubbard, M.D.

Role: STUDY_CHAIR

Hubbard Foundation

Locations

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Vascular Access Center of Downey

Downey, California, United States

Site Status

North County Radiology

Oceanside, California, United States

Site Status

Vascular Access Care of Atlanta

Atlanta, Georgia, United States

Site Status

Columbia endovascular Associates

New York, New York, United States

Site Status

Valley Endovascular Associates

Poughkeepsie, New York, United States

Site Status

Dayton Interventional Radiology

Dayton, Ohio, United States

Site Status

Utah Valley Interventional Associates

Provo, Utah, United States

Site Status

Utah Vascular Clinic

Salt Lake City, Utah, United States

Site Status

Vascular Access Center of Seattle

Seattle, Washington, United States

Site Status

Countries

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United States

Related Links

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http://www.hubbardfoundation.org

Related Info

Other Identifiers

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CCSVI Registry

Identifier Type: -

Identifier Source: org_study_id