Multi-center Registry for CCSVI Testing and Treatment

Chronic Cerebrospinal Venous Insufficiency Clinical Trial

— CCSVI  

Official title:

Multi-center Registry for CCSVI Testing and Treatment

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT01205633
• Other study ID #: CCSVI Registry
• Status: Suspended
• Phase: N/A
• First received: September 17, 2010
• Last updated: September 15, 2012
• Start date: September 2010
• Est. completion date: September 2015

Study information

• Verified date: September 2012
• Source: Hubbard Foundation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Description:

more to follow

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 1000
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Time Perspective: Prospective

Related Conditions & MeSH terms

• CCSVI
• Chronic Cerebrospinal Venous Insufficiency
• Venous Insufficiency
• Venous Malformations of CNS Draining Veins

Intervention

Procedure:
• venous angioplasty
catheter venous angioplasty via femoral vein approach

Locations

Country	Name	City	State
United States	Vascular Access Care of Atlanta	Atlanta	Georgia
United States	Dayton Interventional Radiology	Dayton	Ohio
United States	Vascular Access Center of Downey	Downey	California
United States	Columbia endovascular Associates	New York	New York
United States	North County Radiology	Oceanside	California
United States	Valley Endovascular Associates	Poughkeepsie	New York
United States	Utah Valley Interventional Associates	Provo	Utah
United States	Utah Vascular Clinic	Salt Lake City	Utah
United States	Vascular Access Center of Seattle	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Hubbard Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Short-Form 36 (SF36) Quality of Life Instrument		Baseline and at 1, 6 and 12 months after treatment	No

External Links

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