Multiple SclerosisNCT01201707
Evaluation of Angioplasty in the Treatment of Chronic Cerebrospinal Venous Insufficiency (CCSVI) in Multiple Sclerosis
A study testing Angioplasty and Observation in people with Multiple Sclerosis, run by Community Care Physicians, P.C. at 2 sites in United States.
Trial summary
The study is being done to determine if venous angioplasty is an effective treatment for chronic cerebrospinal venous insufficiency (CCSVI). In this condition, areas of narrowing or blockages are present in the internal jugular or azygos veins (veins which drain blood from the central nervous system) and these… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Angioplasty and Observation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2010to Sep 2013
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients who are willing to comply with the protocol requirements and can be contacted by telephone
- Patients 18-60 years of age
- Patients with clinically definite multiple sclerosis by Polman criteria
- Patients with a history of MS as defined above with an EDSS between 3-6.
- Patients with a significant stenosis of the internal jugular or azygos vein on the basis of magnetic resonance venography or Doppler ultrasound.
Who cannot join
- Patients with renal insufficiency based on an estimated GFR <45
- Patients with a known severe allergy to iodine or gadolinium-based contrast agents which cannot be adequately pre-medicated
- Patients with a known allergy to nickel
- Patients who pregnant
- Patients with a contraindication to anticoagulation or anti-platelet medication
- Patients with a contraindication to drugs used for conscious sedation during interventional procedures, including Versed and Fentanyl
Show all 11Show fewer
- Patients with a history of deep venous thrombosis of the lower extremities
- Patients with occlusion of the right and left common femoral veins
- Patients who have had any changes in their disease modifying drug regimen for MS during the 6 months prior to enrollment in this trial. This would include the addition of any new medications, a change in the dosage of any medications, or the removal of any medications from a patient's drug regimen
- Patients with a life expectancy <18 months
- Patients who are currently enrolled or who plan to enroll in other investigations that conflict with follow-up testing or confounds data in this trial
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Albany Medical Center
Albany, New York, 12208
Image Care Latham
Latham, New York, 12110
About this study
Official title: The Effectiveness of Endovascular Treatment of Chronic Cerebrospinal Venous Insufficiency (CCSVI) in Patients With Multiple Sclerosis
The study is being done to determine if venous angioplasty is an effective treatment for chronic cerebrospinal venous insufficiency (CCSVI). In this condition, areas of narrowing or blockages are present in the internal jugular or azygos veins (veins which drain blood from the central nervous system) and these blockages may be associated with symptoms classically attributed to MS. Therefore, angioplasty may help to improve the symptoms associated with CCSVI and multiple sclerosis (MS). In this study, the investigators will evaluate the effectiveness of angioplasty in the treatment of CCSVI by comparing two the outcomes of two groups of patients: one group with CCSVI diagnosed on a venogram and treated with angioplasty and one group with CCSVI diagnosed on a venogram but not treated. The patients enrolled in this study, and the neurologist evaluating patients after the procedure, will not know whether or not they were treated with angioplasty.
- Conditions
- Multiple Sclerosis
- Being tested
- Angioplasty, Observation
- Keywords
- Multiple Sclerosis, Angioplasty, Vein
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AngioplastyProcedure or surgery
In this procedure, a small catheter (tube) that is approximately the size of a piece of spaghetti is introduced into the vein that is narrowed based on the findings of the venogram. This catheter has a small balloon on it. That balloon is inflated across the narrowing within the vein with the goal of increasing the diameter of that vein and improving flow within that vein.
ObservationOther
Patients in this arm will be diagnosed with CCSVI based on venography but will receive no intervention. They will be followed in the same manner as patients treated with angioplasty.
| Study group | Role | What they receive |
|---|---|---|
| Treatment of CCSVI with Angioplasty | Experimental | At the time of venography, these patients will have had a significant lesion (blockage) in the internal jugular and/or the azygos vein that will be treated with angioplasty. Receives: Procedure: Angioplasty |
| Observation of CCSVI | Sham comparator | At the time of venography, these patients will have had a significant lesion (blockage) in the internal jugular and/or the azygos vein that will not be treated with angioplasty. These patients will be observed after treatment and compared to those patients who received treatment. Receives: Other: Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of CCSVI treatment on quality of life in patients with MS
This will be assessed using the Multiple Sclerosis Quality of Life-54 (MSQOL-54), which is a health-related quality of life measure that combines generic and MS-specific items into a single, self-report questionnaire.
Measured: 1 Month
Impact of CCSVI treatment on quality of life in patients with MS
This will be assessed using the Multiple Sclerosis Quality of Life-54 (MSQOL-54), which is a health-related quality of life measure that combines generic and MS-specific items into a single, self-report questionnaire.
Measured: 3 Months
Impact of CCSVI treatment on quality of life in patients with MS
This will be assessed using the Multiple Sclerosis Quality of Life-54 (MSQOL-54), which is a health-related quality of life measure that combines generic and MS-specific items into a single, self-report questionnaire.
Measured: 6 Months
Impact of CCSVI treatment on quality of life in patients with MS
This will be assessed using the Multiple Sclerosis Quality of Life-54 (MSQOL-54), which is a health-related quality of life measure that combines generic and MS-specific items into a single, self-report questionnaire.
Measured: 12 Months
Impact of CCSVI treatment on quality of life in patients with MS
This will be assessed using the Multiple Sclerosis Quality of Life-54 (MSQOL-54), which is a health-related quality of life measure that combines generic and MS-specific items into a single, self-report questionnaire.
Measured: 18 Months
Impact of CCSVI treatment on quality of life in patients with MS
This will be assessed using the Multiple Sclerosis Quality of Life-54 (MSQOL-54), which is a health-related quality of life measure that combines generic and MS-specific items into a single, self-report questionnaire.
Measured: 24 Months
Secondary outcomes (23)
Clinical significance of CCSVI in MS patients
This will be assessed clinically using annualized relapse rates, Expanded Disability Status Scale (EDSS) change and change in the timed 25 foot walk.
Measured: 1 month
Superiority of angioplasty to observation for treatment of CCSVI
This will be assessed clinically using annualized relapse rates, EDSS change, and change in the timed 25-foot walk
Measured: 1 month
Incidence of CCSVI in patients with MS
This will be assessed on the basis of the findings on diagnostic venography of the internal jugular and azygos veins, which is the initial procedure performed in these patients.
Measured: 0 Months
Safety of endovascular treatment of CCSVI
This is defined as the number and nature of any procedure-related adverse effects
Measured: 1 month
Target vessel primary and secondary patency
Primary patency is the interval following the initial angioplasty procedure until a reintervention is performed to preserve patency. Secondary patency is defined as the interval following the initial angioplasty procedure until treatment of the vein is abandoned due to an inability to treat the original lesion
Measured: 1 month
Clinical significance of CCSVI in MS patients
This will be assessed clinically using annualized relapse rates, EDSS change and change in the timed 25 foot walk.
Measured: 6 months
Clinical significance of CCSVI in MS patients
This will be assessed clinically using annualized relapse rates, EDSS change and change in the timed 25 foot walk.
Measured: 12 months
Clinical significance of CCSVI in MS patients
This will be assessed clinically using annualized relapse rates, EDSS change and change in the timed 25 foot walk.
Measured: 18 months
Clinical significance of CCSVI in MS patients
This will be assessed clinically using annualized relapse rates, EDSS change and change in the timed 25 foot walk.
Measured: 24 months
Superiority of angioplasty to observation for treatment of CCSVI
This will be assessed clinically using annualized relapse rates, EDSS change, and change in the timed 25-foot walk
Measured: 6 Months
Superiority of angioplasty to observation for treatment of CCSVI
This will be assessed clinically using annualized relapse rates, EDSS change, and change in the timed 25-foot walk
Measured: 12 Months
Superiority of angioplasty to observation for treatment of CCSVI
This will be assessed clinically using annualized relapse rates, EDSS change, and change in the timed 25-foot walk
Measured: 18 Months
Superiority of angioplasty to observation for treatment of CCSVI
This will be assessed clinically using annualized relapse rates, EDSS change, and change in the timed 25-foot walk
Measured: 24 Months
Safety of endovascular treatment of CCSVI
This is defined as the number and nature of any procedure-related adverse effects
Measured: 3 months
Safety of endovascular treatment of CCSVI
This is defined as the number and nature of any procedure-related adverse effects
Measured: 6 months
Safety of endovascular treatment of CCSVI
This is defined as the number and nature of any procedure-related adverse effects
Measured: 12 months
Safety of endovascular treatment of CCSVI
This is defined as the number and nature of any procedure-related adverse effects
Measured: 18 months
Safety of endovascular treatment of CCSVI
This is defined as the number and nature of any procedure-related adverse effects
Measured: 24 months
Target vessel primary and secondary patency
Primary patency is the interval following the initial angioplasty procedure until a reintervention is performed to preserve patency. Secondary patency is defined as the interval following the initial angioplasty procedure until treatment of the vein is abandoned due to an inability to treat the original lesion
Measured: 3 months
Target vessel primary and secondary patency
Primary patency is the interval following the initial angioplasty procedure until a reintervention is performed to preserve patency. Secondary patency is defined as the interval following the initial angioplasty procedure until treatment of the vein is abandoned due to an inability to treat the original lesion
Measured: 6 months
Target vessel primary and secondary patency
Primary patency is the interval following the initial angioplasty procedure until a reintervention is performed to preserve patency. Secondary patency is defined as the interval following the initial angioplasty procedure until treatment of the vein is abandoned due to an inability to treat the original lesion
Measured: 12 months
Target vessel primary and secondary patency
Primary patency is the interval following the initial angioplasty procedure until a reintervention is performed to preserve patency. Secondary patency is defined as the interval following the initial angioplasty procedure until treatment of the vein is abandoned due to an inability to treat the original lesion
Measured: 18 months
Target vessel primary and secondary patency
Primary patency is the interval following the initial angioplasty procedure until a reintervention is performed to preserve patency. Secondary patency is defined as the interval following the initial angioplasty procedure until treatment of the vein is abandoned due to an inability to treat the original lesion
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2010 (estimated)
- Study startAug 2010
- Primary completionSep 2013
- Study completionSep 2013
Why it stopped: Inability to enroll adequate number of patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Community Care Physicians, P.C.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gary Siskin, MD, Albany Medical College
- Investigators
- Gary Siskin, MD, Principal investigator, Albany Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01201707
- Sponsor's protocol ID
- 2794
- Status last verified
- Nov 2013
- First submitted
- 10 Sep 2010
- Last updated
- 26 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Zamboni P, Galeotti R, Menegatti E, Malagoni AM, Gianesini S, Bartolomei I, Mascoli F, Salvi F. A prospective open-label study of endovascular treatment of chronic cerebrospinal venous insufficiency. J Vasc Surg. 2009 Dec;50(6):1348-58.e1-3. doi: 10.1016/j.jvs.2009.07.096.
PubMed 19958985Zamboni P, Menegatti E, Weinstock-Guttman B, Schirda C, Cox JL, Malagoni AM, Hojanacki D, Kennedy C, Carl E, Dwyer MG, Bergsland N, Galeotti R, Hussein S, Bartolomei I, Salvi F, Zivadinov R. The severity of chronic cerebrospinal venous insufficiency in patients with multiple sclerosis is related to altered cerebrospinal fluid dynamics. Funct Neurol. 2009 Jul-Sep;24(3):133-8.
PubMed 20018140Bartolomei I, Salvi F, Galeotti R, Salviato E, Alcanterini M, Menegatti E, Mascalchi M, Zamboni P. Hemodynamic patterns of chronic cerebrospinal venous insufficiency in multiple sclerosis. Correlation with symptoms at onset and clinical course. Int Angiol. 2010 Apr;29(2):183-8.
PubMed 20351674Malagoni AM, Galeotti R, Menegatti E, Manfredini F, Basaglia N, Salvi F, Zamboni P. Is chronic fatigue the symptom of venous insufficiency associated with multiple sclerosis? A longitudinal pilot study. Int Angiol. 2010 Apr;29(2):176-82.
PubMed 20351673Zamboni P, Galeotti R, Menegatti E, Malagoni AM, Tacconi G, Dall'Ara S, Bartolomei I, Salvi F. Chronic cerebrospinal venous insufficiency in patients with multiple sclerosis. J Neurol Neurosurg Psychiatry. 2009 Apr;80(4):392-9. doi: 10.1136/jnnp.2008.157164. Epub 2008 Dec 5.
PubMed 19060024
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Endovascular Treatment of Chronic Cerebrospinal Venous Insufficiency (CCSVI) in Patients With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT01201707
- Acronym / sponsor ID
- 2794
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, Angioplasty, Vein
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Inability to enroll adequate number of patients
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Community Care Physicians, P.C.University, hospital or other
- Study start
- Aug 2010
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 15 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.
The study is being done to determine if venous angioplasty is an effective treatment for chronic cerebrospinal venous insufficiency (CCSVI). In this condition, areas of narrowing or blockages are present in the internal jugular or azygos veins (veins which drain blood from the central nervous system) and these blockages may be associated with symptoms classically attributed to MS. Therefore, angioplasty may help to improve the symptoms associated with CCSVI and multiple sclerosis (MS). In this study, the investigators will evaluate the effectiveness of angioplasty in the treatment of CCSVI by comparing two the outcomes of two groups of patients: one group with CCSVI diagnosed on a venogram and treated with angioplasty and one group with CCSVI diagnosed on a venogram but not treated. The patients enrolled in this study, and the neurologist evaluating patients after the procedure, will not know whether or not they were treated with angioplasty.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment of CCSVI with Angioplasty | Experimental | Procedure: AngioplastyAt the time of venography, these patients will have had a significant lesion (blockage) in the internal jugular and/or the azygos vein that will be treated with angioplasty. |
| Observation of CCSVI | Sham comparator | Other: ObservationAt the time of venography, these patients will have had a significant lesion (blockage) in the internal jugular and/or the azygos vein that will not be treated with angioplasty. These patients will be observed after treatment and compared to those patients who received treatment. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients who are willing to comply with the protocol requirements and can be contacted by telephone
- Patients 18-60 years of age
- Patients with clinically definite multiple sclerosis by Polman criteria
- Patients with a history of MS as defined above with an EDSS between 3-6.
- Patients with a significant stenosis of the internal jugular or azygos vein on the basis of magnetic resonance venography or Doppler ultrasound.
Key exclusion criteria (11 listed)
- Patients with renal insufficiency based on an estimated GFR <45
- Patients with a known severe allergy to iodine or gadolinium-based contrast agents which cannot be adequately pre-medicated
- Patients with a known allergy to nickel
- Patients who pregnant
- Patients with a contraindication to anticoagulation or anti-platelet medication
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 |
|---|---|---|
| AngioplastyIn this procedure, a small catheter (tube) that is approximately the size of a piece of spaghetti is introduced into the vein that is narrowed based on the findings of the venogram. This catheter has a small balloon on it. That balloon is inflated across the narrowing within the vein with the goal of increasing the diameter of that vein and improving flow within that vein. | Procedure or surgery | Treatment of CCSVI with Angioplasty |
| ObservationPatients in this arm will be diagnosed with CCSVI based on venography but will receive no intervention. They will be followed in the same manner as patients treated with angioplasty. | Other | Observation of CCSVI |
Primary outcome
Impact of CCSVI treatment on quality of life in patients with MS
Time frame: 1 Month
This will be assessed using the Multiple Sclerosis Quality of Life-54 (MSQOL-54), which is a health-related quality of life measure that combines generic and MS-specific items into a single, self-report questionnaire.
Impact of CCSVI treatment on quality of life in patients with MS
Time frame: 3 Months
This will be assessed using the Multiple Sclerosis Quality of Life-54 (MSQOL-54), which is a health-related quality of life measure that combines generic and MS-specific items into a single, self-report questionnaire.
Impact of CCSVI treatment on quality of life in patients with MS
Time frame: 6 Months
This will be assessed using the Multiple Sclerosis Quality of Life-54 (MSQOL-54), which is a health-related quality of life measure that combines generic and MS-specific items into a single, self-report questionnaire.
Impact of CCSVI treatment on quality of life in patients with MS
Time frame: 12 Months
This will be assessed using the Multiple Sclerosis Quality of Life-54 (MSQOL-54), which is a health-related quality of life measure that combines generic and MS-specific items into a single, self-report questionnaire.
Impact of CCSVI treatment on quality of life in patients with MS
Time frame: 18 Months
This will be assessed using the Multiple Sclerosis Quality of Life-54 (MSQOL-54), which is a health-related quality of life measure that combines generic and MS-specific items into a single, self-report questionnaire.
Impact of CCSVI treatment on quality of life in patients with MS
Time frame: 24 Months
This will be assessed using the Multiple Sclerosis Quality of Life-54 (MSQOL-54), which is a health-related quality of life measure that combines generic and MS-specific items into a single, self-report questionnaire.
23 secondary outcomes
Clinical significance of CCSVI in MS patients
Time frame: 1 month
Superiority of angioplasty to observation for treatment of CCSVI
Time frame: 1 month
Incidence of CCSVI in patients with MS
Time frame: 0 Months
Safety of endovascular treatment of CCSVI
Time frame: 1 month
Target vessel primary and secondary patency
Time frame: 1 month
Clinical significance of CCSVI in MS patients
Time frame: 6 months
Clinical significance of CCSVI in MS patients
Time frame: 12 months
Clinical significance of CCSVI in MS patients
Time frame: 18 months
Clinical significance of CCSVI in MS patients
Time frame: 24 months
Superiority of angioplasty to observation for treatment of CCSVI
Time frame: 6 Months
Superiority of angioplasty to observation for treatment of CCSVI
Time frame: 12 Months
Superiority of angioplasty to observation for treatment of CCSVI
Time frame: 18 Months
Superiority of angioplasty to observation for treatment of CCSVI
Time frame: 24 Months
Safety of endovascular treatment of CCSVI
Time frame: 3 months
Safety of endovascular treatment of CCSVI
Time frame: 6 months
Safety of endovascular treatment of CCSVI
Time frame: 12 months
Safety of endovascular treatment of CCSVI
Time frame: 18 months
Safety of endovascular treatment of CCSVI
Time frame: 24 months
Target vessel primary and secondary patency
Time frame: 3 months
Target vessel primary and secondary patency
Time frame: 6 months
Target vessel primary and secondary patency
Time frame: 12 months
Target vessel primary and secondary patency
Time frame: 18 months
Target vessel primary and secondary patency
Time frame: 24 months
Results and safety
The study was stopped early (reason given: Inability to enroll adequate number of patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2013.
- Background: PubMed 19958985Zamboni P, Galeotti R, Menegatti E, Malagoni AM, Gianesini S, Bartolomei I, Mascoli F, Salvi F. A prospective open-label study of endovascular treatment of chronic cerebrospinal venous insufficiency. J Vasc Surg. 2009 Dec;50(6):1348-58.e1-3. doi: 10.1016/j.jvs.2009.07.096.
- Background: PubMed 20018140Zamboni P, Menegatti E, Weinstock-Guttman B, Schirda C, Cox JL, Malagoni AM, Hojanacki D, Kennedy C, Carl E, Dwyer MG, Bergsland N, Galeotti R, Hussein S, Bartolomei I, Salvi F, Zivadinov R. The severity of chronic cerebrospinal venous insufficiency in patients with multiple sclerosis is related to altered cerebrospinal fluid dynamics. Funct Neurol. 2009 Jul-Sep;24(3):133-8.
- Background: PubMed 20351674Bartolomei I, Salvi F, Galeotti R, Salviato E, Alcanterini M, Menegatti E, Mascalchi M, Zamboni P. Hemodynamic patterns of chronic cerebrospinal venous insufficiency in multiple sclerosis. Correlation with symptoms at onset and clinical course. Int Angiol. 2010 Apr;29(2):183-8.
- Background: PubMed 20351673Malagoni AM, Galeotti R, Menegatti E, Manfredini F, Basaglia N, Salvi F, Zamboni P. Is chronic fatigue the symptom of venous insufficiency associated with multiple sclerosis? A longitudinal pilot study. Int Angiol. 2010 Apr;29(2):176-82.
- Background: PubMed 19060024Zamboni P, Galeotti R, Menegatti E, Malagoni AM, Tacconi G, Dall'Ara S, Bartolomei I, Salvi F. Chronic cerebrospinal venous insufficiency in patients with multiple sclerosis. J Neurol Neurosurg Psychiatry. 2009 Apr;80(4):392-9. doi: 10.1136/jnnp.2008.157164. Epub 2008 Dec 5.
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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.
Gary Siskin, MD principal investigator
Albany Medical College
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Angioplasty and Observation in people with Multiple Sclerosis, run by Community Care Physicians, P.C. at 2 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 5 inclusion and 11 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 26 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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. 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 (reason given: Inability to enroll adequate number of patients). 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?
Impact of CCSVI treatment on quality of life in patients with MS (time frame: 1 Month). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01201707, which also lists 5 linked publications.
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 26 Nov 2013.