Trial from ANZCTR


Trial ID ACTRN12612000302853
Trial Status: Registered
Date Submitted: 9/03/2012
Date Registered: 16/03/2012
Prospectively registered

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Public title A randomised, blinded, controlled study of percutaneous transluminal angioplasty (PTA) for extracranial vein stenoses in patients with multiple sclerosis (MS)
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Study title in 'Participant- Intervention- Comparator- Outcome (PICO)' format In multiple sclerosis patients with extracranial and/or azygos vein stenosis, is percutaneous balloon angioplasty more effective than a sham procedure in terms of changes to physical, neurological and cognitive function?
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Secondary ID [1] 279953 0
Nil known
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UTN
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Trial acronym MS PTA study
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Health condition(s) or problem(s) studied:
Extracranial and/or azygous vein stenoses in patients with Multiple Sclerosis 285868 0
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Condition category: Condition code:
Neurological Multiple sclerosis
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286053 286053 0 0
Cardiovascular Diseases of the vasculature and circulation including the lymphatic system
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286229 286229 0 0

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Descriptions of intervention(s) / exposure Percutaneous Transluminal Angioplasty (PTA) is a minimally invasive procedure done under sedation and with image guidance using x-rays called angiography. It takes about an hour and a half to two hours. A fine wire called a catheter containing a small inflatable balloon is moved through the veins to the point of narrowing. At that point the balloon is inflated stretching and opening the vein. The catheter and balloon are then pulled back and removed from the veins. Participants will be randomised to the treatment group, angiography + PTA,or to the control group who will have the angiogram without the ballooning. The participants and neurologists will not know who has had the treatment. At 12 months all participants will have another angiogram. The participants that were originally inthe control group will have the ballooning at 12 months. The participants and neurologists will not know at which time point the ballooning was performed.
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Intervention Code:
Treatment: surgery 284284 0
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Comparator / control treatment PTA procedure compared to the control group. The control group will get a sham PTA procedure (the angiogram without the ballooning) at the beginning of the study. The control group will cross over to the treatment arm at 12 months. The study will be double blinded (the neurologist and the patients will not know at which time point, 0 or 12 months, the PTA procedure was performed.
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Control group Placebo
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Primary Outcome: Change in clinical parameters and disease progression as measured by Kurtzke Extended Disability Status Scale (EDSS) 286534 0
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Timepoint: One week; one, three, six and twelve months compared to baseline 286534 0
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Primary Outcome: Change in clinical parameters and disease progression as measured by the Multiple Sclerosis Functional Composite Score (MSFC). 286669 0
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Timepoint: One week; one, three, six and twelve months compared to baseline 286669 0
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Primary Outcome: Change in clinical parameters and disease progression as measured by Cognitive Assessment Tool (CogState). 286670 0
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Timepoint: One week; one, three, six and twelve months compared to baseline 286670 0
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Secondary Outcome: 1. Composite number of procedural and post procedural adverse events (to 12 months) measured Common Terminology Criteria for Adverse Events v 4 (CTCAE), 296104 0
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Timepoint: One week; one, three, six and twelve months compared to baseline 296104 0
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Secondary Outcome: Restoration of venous outflow (to 75% from normal outflow) as measured by venogram, US and MRV at six and 12 months. 296419 0
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Timepoint: Six and twelve months compared to baseline 296419 0
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Secondary Outcome: Change in patient reported quality of life measured by the Multiple Sclerosis Quality of Life-54 Instrument (MSQoL-54) 296420 0
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Timepoint: One week; one, three, six and twelve months compared to baseline 296420 0
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Secondary Outcome: Change in patient reported fatigue as measured by the Fatigue Severity Scale (FSS) 296421 0
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Timepoint: One week; one, three, six and twelve months compared to baseline 296421 0
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Key inclusion criteria *Signed Participant Information and Consent Form;
*Age 18 to 65 years;
*Expanded Disability Disease Scale Score (EDSS) ranging from 0 to 7.5;
*Diagnosis of MS according to the revised McDonald criteria;
*Therapy with currently approved disease-modifying treatments;
*Normal renal function or pre-hydration;
*No allergy to contrast media or pre-treatment;
*Abnormal extracranial vein venogram:
1. Stenosis at any level
2. Abnormal filling of vertebral veins following a jugular bulb injection
3. Delayed emptying of the internal jugular vein in the supine position
4. Persistent filling of the internal jugular vein in the erect position
5. Abnormal appearance of the internal jugular valve
6. Stenosis of the thoracic azygos vein
7. Delayed emptying of the thoracic azygos vein.
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Minimum age 18 Years
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Maximum age 65 Years
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Gender Both males and females
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Healthy volunteers? No
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Key exclusion criteria *pregnancy or planning a pregnancy within the next two years
*Relapse, disease progression, and steroid treatment in the 30 days preceding study entry (all conditions significantly modify clinical parameters, rendering unreliable any postoperative assessment);
*Pre-existing medical conditions known to be associated with brain pathology, including neurodegenerative disorder, cerebrovascular disease, and history of alcohol abuse; *Abnormal renal function with a calculated e-GFR <60 and pre-hydration not possible;
*Allergy to contrast and pre-treatment not possible; *Refusal to undergo the endovascular treatment or randomisation.
*Previous PTA on extracranial veins
*Unable to adequately perform the CogState cognitive assessment tool because of visual or manual dexterity impairment.
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Study type Interventional
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Purpose of the study Treatment
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Allocation to intervention Randomised controlled trial
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Describe the procedure for enrolling a subject and allocating the treatment (allocation concealment procedures) Potential participants will have a consultation with the study radiologist and have the procedure and risks described. They will be given a copy of the the Participants Information and Consent Form and the research coordinators' contact number. Potential participants will be asked to take time to consider their voluntary participation in the study. They will be told that if they decide to participate they will need to contact the research coordinators for an appointment. The coordinators will question the potential participants about their understanding of the study, ask if they have any concerns or further questions prior to obtaining consent. If further consultation is required with the radiologist for explanation of the procedure this will be organised. If consent is obtained the potiential participants will then have their screening and baseline imaging and their neurological and cognitive assessment with the study neurologist to determine eligibility to participate. When eligibility is confirmed the procedure (angiogram +/- PTA) date will be scheduled. The radiologist will be given the allocated randomisation for each participant at the start of the angiogram procedure . The participants and neurologists will be blinded, that is they will not know at which time point, at start of the study or at 12 months, the PTA procedure was performed.
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Describe the methods used to generate the sequence in which subjects will be randomised (sequence generation) The Alfred biostatistician will be asked to generate a randomisation list. Participants will be randomised to an angiogram plus the PTA or to just the angiogram without the PTA. Dark brown envelopes with sequential numbers one to 180 will be perpared. The envelopes will contain the randomisation allocation as per the list generated by the biostatistician. The envelopes will be stored in a locked cupboard; they will be given to the radiologist sequentially at the start of the angiography procedure.
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Masking / blinding Blinded (masking used)
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Who is / are masked / blinded (choose all that apply)


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Assignment Crossover
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Other design features The participants in the control group, that is the group that get the angiogram without the PTA at the start of the study, will cross over to the PTA trreatment arm at 12 months. All participants and the neurologists will not know whether the PTA was performed at the start of the study or at 12 months.
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Type of endpoint(s) Efficacy
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Statistical Methods/Analysis
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Phase Not Applicable
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Anticipated date of first participant enrolment 1/04/2012
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Date of first participant enrolment
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Anticipated date last participant recruited/enrolled
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Actual date last participant recruited/enrolled
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Target sample size 160
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Recruitment status Completed
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Recruitment in Australia

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Recruitment outside Australia

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Funding Source: Other 284722 0
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Name: The Alfred Radiology Research Fund 284722 0
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Address: Radiology Department
The Alfred
55 Commercial Road
Melbourne, Vic 3004
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Country: Australia 284722 0
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Primary Sponsor Other
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Name: The Alfred Hospital
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Address: The Alfred
55 Commercial Road
Melbourne, Vic 3004
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Country: Australia
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Secondary Sponsor: None 283732 0
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Has the study received approval from at least one Ethics Committee? Yes
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Ethics Committee name: The Alfred Human Research Ethics Committee 286726 0
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Address: Ground Floor
Commercial Road
Melbourne, Victoria, 3004
286726 0
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Country: Australia 286726 0
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Approval Date: 06/02/2012 286726 0
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Submitted Date: 15/05/2011 286726 0
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HREC: 1/11/0120 286726 0
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Brief summary To assess the safety and effectiveness of percutaneous transluminal angioplasty (PTA) for the treatment of extracranial and/or azygous vein stenosis in MS patients as measured by clinical parameters of physical and mental disability progression.
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Trial website N/A
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Trial related presentations / publications N/A
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Public Notes
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Principal Investigator
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Contact person for public queries
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Name: Helen Kavnoudias
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Address: Radiology Research Unit RAdiology Department The Alfred Level 1 Phillip Block 55 Commercial Road Melbourne, Vic, 3004
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Country: Australia
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Tel: +61 3 9076 3606
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Fax: +61 3 9076 2153
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Email: h.kavnoudias@alfred.org.au
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Contact person for scientific queries
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Name: Helen Kavnoudias
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Address: Radiology Research Unit RAdiology Department The Alfred Level 1 Phillip Block 55 Commercial Road Melbourne, Vic, 3004
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Country: Australia
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Contact person responsible for updating information
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Name: Helen Kavnoudias
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Address: Radiology Research Unit RAdiology Department The Alfred Level 1 Phillip Block 55 Commercial Road Melbourne, Vic, 3004
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Country: Australia
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Tel: +61 3 9076 3606
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Addition Cancer fields
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