Multi-center Registry for CCSVI Testing and Treatment | NCT01205633

Status Module

Record Verification Date

Sep 2012

Overall Recruitment Status or Expanded Access Status

Suspended

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

9/12/12 FDA stopped enrollment pending device exemption(IDE)application.

Expanded Access Info

Start Date

Sep 2010

Primary Completion Date

Sep 2015Estimated

Completion Date

Sep 2015Estimated

First Submitted Date

Sep 17, 2010

First Submission Date that Met QC Criteria

Sep 17, 2010

First Posted Date

Sep 20, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 15, 2012

Last Update Posted Date

Sep 18, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CNS draining vein abnormalities			Procedure: venous angioplasty

Interventions

Name	Type	Description	Arm Group Labels	Other Names
venous angioplasty	Procedure	catheter venous angioplasty via femoral vein approach	CNS draining vein abnormalities

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Patients suspected of obstructions in the veins draining the central nervous system which may adversely affect CNS function

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
David R Hubbard, M.D.	Hubbard Foundation	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Vascular Access Center of Downey		Downey	California	90241	United States
North County Radiology

Label	URL
Related Info	View source

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

ID	Term
D019636	Neurodegenerative Diseases
D005221	Fatigue

ID	Term
D009422	Nervous System Diseases
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms