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Conducted by:
Gary Siskin, MD, Professor and Chairman Department of Radiology  (primary investigator),
Description:
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.

* Incidence of major adverse events [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
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.

 Secondary Outcome Measures:

* Clinical significance of CCSVI in MS patients [ Time Frames: 1 month, 6 months, 12 months, 18 months, 24 months ]
[ Designated as safety issue: No ]
This will be assessed clinically using annualized relapse rates, Expanded Disability Status Scale (EDSS) change and change in the timed 25 foot walk.

* Superiority of angioplasty to observation for treatment of CCSVI [ Time Frames: 1 month, 6 months, 12 months, 18 months, 24 months ] [ Designated as safety issue: No ]
This will be assessed clinically using annualized relapse rates, EDSS change, and change in the timed 25-foot walk

* Incidence of CCSVI in patients with MS [ Time Frame: 0 Months ] [ Designated as safety issue: No ]
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.

* Safety of endovascular treatment of CCSVI [ Time Frames: 1 month, 3 months, 6 months, 12 months, 18 months, 24 months ] [ Designated as safety issue: Yes ]
This is defined as the number and nature of any procedure-related adverse effects

* Target vessel primary and secondary patency [ Time Frames: 1 month, 3 months, 6 months, 12 months, 18 months, 24 months ] [ Designated as safety issue: No ]
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

* Mortality [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Secondary endpoints will be evaluated with all subjects based upon mortality, incidence of all secondary interventions and incidence of all major adverse events for a period of 2 years.

Estimated Enrollment: 130
Study Start Date: August 2010
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)

Intervention Details:

Conducted by:
Dr. Manish Mehta, MD, MPH   (primary investigator),
Description:
Study to evaluate treating chronic cerebrospinal venous insufficiency (CCSVI) in multiple sclerosis patients.

* Incidence of major adverse events [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
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.

Secondary Outcome Measures:

* Mortality [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Secondary endpoints will be evaluated with all subjects based upon mortality, incidence of all secondary interventions and incidence of all major adverse events for a period of 2 years.

Estimated Enrollment: 500
Study Start Date: August 2010
Estimated Study Completion Date: September 2011
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Intervention Details:

* Procedure: Angioplasty
To identify the presence of CCSVI, all patients will undergo a clinical evaluation by a neurologist, a duplex ultrasound of central extracranial venous system, an MRV, and a venogram. The decision to enroll patient in percutaneous angioplasty for CCSVI will be made at the time of venogram, in select patients that have greater than or equal to 50 percent stenosis of the extracranial central veins including the internal jugular veins and the azygos vein. Extracranial venous ultrasound will be performed at 3, 6, 12, 18, and 24 months following the procedure or if clinical symptoms recur. MRV and venograms will be performed at 12months and 24 months or if clinical symptoms recur.

Reports:

Study To Evaluate Treating Chronic Cerebrospinal Venous Insufficiency (CCSVI) in Multiple Sclerosis Patients

V-Aware, Vol 2 Issue 3, CCSVI and Multiple Sclerosis, 2010 November 

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Conducted by:
Adnan Siddiqui, MD, assistant professor of Neurosurgery, UB School of Medicine and Biomedical Sciences (principal investigator)
Elad Levy, MD, associate professor UB Department of Neurosurgery (co-principal investigator)
L.N. Hopkins, MD,professor and chair, UB Department of Neurosurgery (co-principal investigator)
In collaboration with:
Additional independent researchers from University at Buffalo to participate in the evaluation and follow-up of study patients.
Study Numbers:
Phase 1, ten MS patients from the USA and Canada to undergo venous angioplasties to determine safety
Phase II, 20 MS patients randomised to undergo either venous angioplasty or a sham angioplasty
Description:
The objective is to determine if endovascular intervention via balloon angioplasty to correct the blockages improves MS symptoms or progression. PREMiSe is believed to be the first IRB-approved prospective randomized double-blinded study of balloon angioplasty for MS being performed in a rigorous fashion in the US with significant safeguards in place to ensure careful determination of risks and benefits. An independent Data Safety Monitoring Board (DSMB) will ensure the safety and effectiveness of the study on an ongoing basis. In the first phase of the study, ten MS patients from the United States and Canada exhibiting venous insufficiency will undergo minimally invasive venous angioplasties to determine if the procedure can be performed safely. The procedures, scheduled for June 29 and 30, 2010, will be performed by Drs. Siddiqui and Levy at Kaleida Healths Millard Fillmore Gates Hospital in Buffalo, New York. The second phase of the study will randomize 20 MS patients to undergo either venous angioplasty or a sham angioplasty (i.e. a catheter will be inserted but there will be no inflation of the balloon). The treatment will be blinded in such a way that neither the patient undergoing the procedure nor the clinicians evaluating the patient will be aware which procedure was performed. If results suggest an appropriate safety profile and preliminary effectiveness, then researchers will approach the University at Buffalo Institutional Review Board (IRB) for an extension of the protocol to study a larger number of patients in order to convincingly prove or disprove a causal relationship between CCSVI and MS.

Reports:

Interview with Dr Siddiqui and Dr Levy: July 16 2010 WKBW 7am Buffalo News Programme, Part 1
Interview with Dr Siddiqui and Dr Levy: July 16 2010 WKBW 7am Buffalo News Programme, Part 2

UB launches clinical trial of new MS treatment July 05 2010, UB Reporter
University at Buffalo Launches Clinical Trial Of New Multiple Sclerosis Treatment: June 30 2010, UB Press Release
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Conducted by:
Dr. Tariq Sinan (primary investigator), Consultant Interventional Radiologist
Dr. Hussein Safar, Consultant Vascular Surgeon
Dr. AbdulAziz Almuzaini, Vascular Imaging Consultant
Dr. Sulaiman Al Khashan, Consultant Neurologist
Study Numbers:
62 MS patients have been enrolled (envisaged numbers 100-500)
Description:
The objective is to diagnose MS patients with Chronic cerebrospinal venous insufficiency (CCSVI) and to evaluate them with Duplex scanning and magnetic resonance venography, to evaluate clinical and or radiological improvement of these cases after treating them with angioplasty (with or without stent) of the diseased affected part of the internal jugular vein.

Reports:

Chronic Cerebrospinal Venous Insufficiency in Multiple Sclerosis patients - Kuwait:   May 04 2010

Download Study Introduction as PDF:     Kuwait CCSVI Study Introduction
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Conducted by:
Zamboni P (primary investigator), Galeotti R, Weinstock-Guttman B, Cutter G, Menegatti E, Malagoni AM, Bartolomei I, Cox JL, Salvi F, and Zivadinov R:.

Study Numbers:

16  persons

Reports:

Download Study Abstract as PDF:     Abstract - Ferrara/Buffalo

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