CCSVICCSVINCT01205633
Multi-center Registry for CCSVI Testing and Treatment
An observational study of CCSVI and Chronic Cerebrospinal Venous Insufficiency, run by Hubbard Foundation at 9 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- CCSVI, Chronic Cerebrospinal Venous Insufficiency, Venous Malformations of CNS Draining Veins
- What is being tested?
- venous angioplasty
- Type of treatment
- Surgery or procedure
- How many people
- 1,000 participants
- Where
- 9 sitesUnited States
- Study dates
- Sep 2010to Sep 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients suspected of obstructions in the veins draining the central nervous system which may adversely affect CNS function
Who may be able to join
- Referral by patients primary treating physician for suspected CCSVI
Who cannot join
- 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
- -
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Vascular Access Care of Atlanta
Atlanta, Georgia, 30309
Dayton Interventional Radiology
Dayton, Ohio, 45409
Vascular Access Center of Downey
Downey, California, 90241
Columbia endovascular Associates
New York, New York, 10022
North County Radiology
Oceanside, California, 92056
Valley Endovascular Associates
Poughkeepsie, New York, 12601
Utah Valley Interventional Associates
Provo, Utah, 84604
Utah Vascular Clinic
Salt Lake City, Utah, 84107
Vascular Access Center of Seattle
Seattle, Washington, 14220
About this study
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.
Read the detailed description
more to follow
- Conditions
- CCSVI, Chronic Cerebrospinal Venous Insufficiency, Venous Malformations of CNS Draining Veins
- Being tested
- venous angioplasty
- Keywords
- neurodegenerative disease, neurovascular disease, fatigue, Hubbard Foundation, angioplasty
- Medical subject headings
- Neurodegenerative Diseases, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
venous angioplastyProcedure or surgery
catheter venous angioplasty via femoral vein approach
| Study group | Role | What they receive |
|---|---|---|
| CNS draining vein abnormalities | Not described Receives: Procedure: venous angioplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short-Form 36 (SF36) Quality of Life Instrument
Measured: Baseline and at 1, 6 and 12 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2010 (estimated)
- Study startSep 2010
- Primary completionSep 2015 (estimated)
- Study completionSep 2015 (estimated)
Why it stopped: 9/12/12 FDA stopped enrollment pending device exemption(IDE)application.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CCSVIStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hubbard Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David R Hubbard, M.D., Study chair, Hubbard Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01205633
- Sponsor's protocol ID
- CCSVI Registry
- Acronym
- CCSVI
- Status last verified
- Sep 2012
- First submitted
- 17 Sep 2010
- Last updated
- 18 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center Registry for CCSVI Testing and Treatment
- ClinicalTrials.gov ID
- NCT01205633
- Acronym / sponsor ID
- CCSVI / CCSVI Registry
- Conditions
- CCSVI, Chronic Cerebrospinal Venous Insufficiency, Venous Malformations of CNS Draining Veins
- Keywords
- neurodegenerative disease, neurovascular disease, fatigue, Hubbard Foundation, angioplasty
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: 9/12/12 FDA stopped enrollment pending device exemption(IDE)application.
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Hubbard FoundationUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Sep 2015 (estimated)
- Study completion
- Sep 2015 (estimated)
- First posted
- 20 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CNS draining vein abnormalities | – | Procedure: venous angioplasty |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients suspected of obstructions in the veins draining the central nervous system which may adversely affect CNS function
Key inclusion criteria (1 listed)
- Referral by patients primary treating physician for suspected CCSVI
Key exclusion criteria (2 listed)
- 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
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| venous angioplastycatheter venous angioplasty via femoral vein approach | Procedure or surgery | CNS draining vein abnormalities |
Primary outcome
Short-Form 36 (SF36) Quality of Life Instrument
Time frame: Baseline and at 1, 6 and 12 months after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2012.
- Related InfoLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David R Hubbard, M.D. study chair
Hubbard Foundation
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of CCSVI and Chronic Cerebrospinal Venous Insufficiency, run by Hubbard Foundation at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 18 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short-Form 36 (SF36) Quality of Life Instrument (time frame: Baseline and at 1, 6 and 12 months after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2012.