Multi-center Registry for CCSVI Testing and Treatment

Suspended

• Conditions: CCSVI; Chronic Cerebrospinal Venous Insufficiency; Venous Malformations of CNS Draining Veins
• Interventions: Procedure: venous angioplasty

• Registration Number: NCT01205633
• Lead Sponsor: Hubbard Foundation

Brief Summary

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

more to follow

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2010-09-17
• Study First Submitted QC: 2010-09-17
• Study First Posted: 2010-09-20
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-15
• Last Update Posted: 2012-09-18
• Primary Completion: 2015-09
• Study Completion: 2015-09

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 1000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CNS draining vein abnormalities	venous angioplasty	-

Primary Outcome Measures

Name	Time	Method
Short-Form 36 (SF36) Quality of Life Instrument	Baseline and at 1, 6 and 12 months after treatment

Trial Locations

Locations (9)

Utah Vascular Clinic; 🇺🇸 Salt Lake City, Utah, United States

Dayton Interventional Radiology; 🇺🇸 Dayton, Ohio, United States

Columbia endovascular Associates; 🇺🇸 New York, New York, United States

North County Radiology; 🇺🇸 Oceanside, California, United States

Vascular Access Care of Atlanta; 🇺🇸 Atlanta, Georgia, United States

Vascular Access Center of Downey; 🇺🇸 Downey, California, United States

Utah Valley Interventional Associates; 🇺🇸 Provo, Utah, United States

Valley Endovascular Associates; 🇺🇸 Poughkeepsie, New York, United States

Vascular Access Center of Seattle; 🇺🇸 Seattle, Washington, United States