A randomised, blinded, controlled study of percutaneous transluminal angioplasty (PTA) for extracranial vein stenoses in patients with multiple sclerosis (MS)

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?

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12612000302853

Acronym

MS PTA study

Enrollment

160

Registered

2012-03-16

Start date

2012-04-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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.

Study design

Allocation

Randomised controlled trial

Intervention model

Crossover

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Healthy volunteers

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.

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.

Outcome results