Multiple SclerosisNCT01089686
Study To Evaluate Treating Chronic Cerebrospinal Venous Insufficiency (CCSVI) in Multiple Sclerosis Patients
A study testing Venoplasty in people with Multiple Sclerosis, run by Manish Mehta, MD at 1 site in United States.
Trial summary
This is a single center, multispecialty, randomized double blind placebo control feasibility clinical trial. The purpose is to evaluate the safety, feasibility and efficacy of percutaneous transluminal angioplasty in treating extracranial venous obstructive lesions, and its influence on the clinical outcomes of… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Venoplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2010to Oct 2012
- Phase
- Interventional
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Must be 18 years old or greater and less than or equal to 65 years of age
- Score of 0 to 7 on the EDSS scale
- Diagnosis of relapsing remitting or secondary progressive Multiple Sclerosis by a neurologist and confirmed by one of the independent study neurologists
- Presence of greater than or equal to 50 percent stenosis of the extracranial veins as determined by venogram
- Informed consent signed by patient
Who cannot join
- Patient is unwilling to comply with the follow up
- Patient is pregnant
- Diagnosis of primary progressive MS by a certified neurologist confirmed by one of the study neurologists
- Presence of less than 50 percent stenosis of the extracranial veins as determined by venogram
- Presence of other medical illnesses or a psychiatric condition that in the opinion of the investigator may cause the subject to be non-compliant with the protocol requirements
- Life expectancy is less than one year
Show all 9Show fewer
- Lack of mental capacity to consent
- Creatinine level of greater than 2.5 or is dialysis dependant
- Enrollment in another clinical study
Trial locations and contacts
1 site in 1 country.
United States1 site
The Vascular Group, PLLC, The Vascular Health Pavillion
Albany, New York, 12205
About this study
Official title: Utility of Chronic Cerebrospinal Venous Insufficiency Percutaneous Angioplasty for Multiple Sclerosis: The Albany Vascular Group Study (Liberation Study)
This is a single center, multispecialty, randomized double blind placebo control feasibility clinical trial. The purpose is to evaluate the safety, feasibility and efficacy of percutaneous transluminal angioplasty in treating extracranial venous obstructive lesions, and its influence on the clinical outcomes of Multiple Sclerosis (MS) patients that have been found to have chronic cerebrospinal venous insufficiency (CCSVI).
- Conditions
- Multiple Sclerosis
- Being tested
- Venoplasty, Sham procedure (non-treatment)
- Keywords
- Chronic Cerebrospinal Venous Insufficiency
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VenoplastyProcedure or surgery
Venous access is obtained from the groin through the femoral vein. The catheter will be advanced into the veins in the neck and chest. Angiographic images will be taken of the extracranial venous system as well as the azygous vein. These images will be used to confirm CCSVI. Venoplasty is performed by inserting an additional catheter with a balloon at the tip. The balloon will be inflated to open the vessel. Once dilation of the vessel is confirmed, the venous sheath will be removed and manual compression applied to the groin access.
Sham procedure (non-treatment)Procedure or surgery
Venous access is obtained from the groin through the femoral vein. The catheter will be advanced into the veins in the neck and chest. Angiographic images will be taken of the extracranial venous system as well as the azygous vein. These images will be used to confirm CCSVI. Since the patient has been randomized to the non-treatment arm of the trial, the procedure will end without venoplasty. After completion of the diagnostic venogram, the venous sheath will be removed and manual compression applied to the groin access.
| Study group | Role | What they receive |
|---|---|---|
| Venoplasty (treatment) | Active comparator | Patients will be randomized to treatment or non-treatment arm with a 2:1 ratio. Patients who meet the inclusion/exclusion criteria and who are randomized to the treatment arm of the study will receive venoplasty at the time of the diagnostic venogram. Receives: Procedure: Venoplasty |
| Sham procedure (non-treatment) | Sham comparator | Patients will be randomized to treatment or non-treatment with a 2:1 ratio. Patients who meet the inclusion/exclusion criteria and who are randomized to the non-treatment arm of the study will receive the diagnostic venogram only. Receives: Procedure: Sham procedure (non-treatment) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of major adverse events
The evaluation of safety will be defined as the incidence of major adverse events at 30 days following the index procedure. The evaluation of feasibility and efficacy will be determined by those patients that do not have more than 50 percent restenosis within the 30 day time frame.
Measured: 30 days
Neurological assessment of MS
An independant neurologist will assess the number of MS attacks that have occurred during one year follow up period.
Measured: 1 year
MRI/MRA evaluation of MS lesions, recommended
Evaluation of imaging to reveal local iron content, change in MS lesions and oxygen saturation changes using conventional MRA/MRI methods by an independant radiologist.
Measured: 1 year
Secondary outcomes (3)
Mortality
All cause mortality will be evaluated through one year.
Measured: 1 year
Major adverse events
Incidence of all major adverse events will be collected for one year.
Measured: 1 year
Identification of central venous stenosis
Evaluation of the correlation between MRV, Duplex Ultrasound and Venogram in identifying central venous stenosis.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2010 (estimated)
- Study startAug 2010
- Primary completionOct 2012 (estimated)
- Study completionOct 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Manish Mehta, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Center for Vascular Awareness, Albany, New York
- Responsible party
- Sponsor-investigator, Manish Mehta, MD, The Vascular Group, PLLC
- Investigators
- Manish Mehta, MD, MPH, Principal investigator, The Vascular Group, PLLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01089686
- Sponsor's protocol ID
- LS10-01
- Status last verified
- Mar 2012
- First submitted
- 17 Mar 2010
- Last updated
- 7 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utility of Chronic Cerebrospinal Venous Insufficiency Percutaneous Angioplasty for Multiple Sclerosis: The Albany Vascular Group Study (Liberation Study)
- ClinicalTrials.gov ID
- NCT01089686
- Acronym / sponsor ID
- LS10-01
- Conditions
- Multiple Sclerosis
- Keywords
- Chronic Cerebrospinal Venous Insufficiency
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Manish Mehta, MDUniversity, hospital or other
- Collaborators
- Center for Vascular Awareness, Albany, New York
- Study start
- Aug 2010
- Primary completion
- Oct 2012 (estimated)
- Study completion
- Oct 2012 (estimated)
- First posted
- 18 Mar 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.
This is a single center, multispecialty, randomized double blind placebo control feasibility clinical trial. The purpose is to evaluate the safety, feasibility and efficacy of percutaneous transluminal angioplasty in treating extracranial venous obstructive lesions, and its influence on the clinical outcomes of Multiple Sclerosis (MS) patients that have been found to have chronic cerebrospinal venous insufficiency (CCSVI).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Venoplasty (treatment) | Active comparator | Procedure: VenoplastyPatients will be randomized to treatment or non-treatment arm with a 2:1 ratio. Patients who meet the inclusion/exclusion criteria and who are randomized to the treatment arm of the study will receive venoplasty at the time of the diagnostic venogram. |
| Sham procedure (non-treatment) | Sham comparator | Procedure: Sham procedure (non-treatment)Patients will be randomized to treatment or non-treatment with a 2:1 ratio. Patients who meet the inclusion/exclusion criteria and who are randomized to the non-treatment arm of the study will receive the diagnostic venogram only. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Must be 18 years old or greater and less than or equal to 65 years of age
- Score of 0 to 7 on the EDSS scale
- Diagnosis of relapsing remitting or secondary progressive Multiple Sclerosis by a neurologist and confirmed by one of the independent study neurologists
- Presence of greater than or equal to 50 percent stenosis of the extracranial veins as determined by venogram
- Informed consent signed by patient
Key exclusion criteria (9 listed)
- Patient is unwilling to comply with the follow up
- Patient is pregnant
- Diagnosis of primary progressive MS by a certified neurologist confirmed by one of the study neurologists
- Presence of less than 50 percent stenosis of the extracranial veins as determined by venogram
- Presence of other medical illnesses or a psychiatric condition that in the opinion of the investigator may cause the subject to be non-compliant with the protocol requirements
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 |
|---|---|---|
| VenoplastyVenous access is obtained from the groin through the femoral vein. The catheter will be advanced into the veins in the neck and chest. Angiographic images will be taken of the extracranial venous system as well as the azygous vein. These images will be used to confirm CCSVI. Venoplasty is performed by inserting an additional catheter with a balloon at the tip. The balloon will be inflated to open the vessel. Once dilation of the vessel is confirmed, the venous sheath will be removed and manual compression applied to the groin access. | Procedure or surgery | Venoplasty (treatment) |
| Sham procedure (non-treatment)Venous access is obtained from the groin through the femoral vein. The catheter will be advanced into the veins in the neck and chest. Angiographic images will be taken of the extracranial venous system as well as the azygous vein. These images will be used to confirm CCSVI. Since the patient has been randomized to the non-treatment arm of the trial, the procedure will end without venoplasty. After completion of the diagnostic venogram, the venous sheath will be removed and manual compression applied to the groin access. | Procedure or surgery | Sham procedure (non-treatment) |
Primary outcome
Incidence of major adverse events
Time frame: 30 days
The evaluation of safety will be defined as the incidence of major adverse events at 30 days following the index procedure. The evaluation of feasibility and efficacy will be determined by those patients that do not have more than 50 percent restenosis within the 30 day time frame.
Neurological assessment of MS
Time frame: 1 year
An independant neurologist will assess the number of MS attacks that have occurred during one year follow up period.
MRI/MRA evaluation of MS lesions, recommended
Time frame: 1 year
Evaluation of imaging to reveal local iron content, change in MS lesions and oxygen saturation changes using conventional MRA/MRI methods by an independant radiologist.
3 secondary outcomes
Mortality
Time frame: 1 year
Major adverse events
Time frame: 1 year
Identification of central venous stenosis
Time frame: 1 year
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2012.
- The Center for Vascular AwarenessLink provided by the sponsor.
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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.
Manish Mehta, MD, MPH principal investigator
The Vascular Group, PLLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Venoplasty in people with Multiple Sclerosis, run by Manish Mehta, MD at 1 site 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 5 inclusion and 9 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: stopped early, as of the sponsor's last update on 7 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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?
The study was stopped early. 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?
Incidence of major adverse events (time frame: 30 days). The study lists 3 primary outcomes in all. 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 7 Mar 2012.