CompletedNCT05380362PREMiSeUpdated Aug 22, 2025Results posted

Prospective Randomized Endovascular Therapy in Multiple Sclerosis

An interventional study of Venous Angioplasty and Sham Angioplasty in Multiple Sclerosis, sponsored by University at Buffalo. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-08-22.

Sponsored by University at Buffalo · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 30
Allocation: Randomized
Ages: 18 Years to 65 Years
Sex: All

Study summary

To assess the safety of endovascular therapy (balloon angioplasty) for venous stenoses in MS patients with CCSVI as documented by sonographic (extracranial echocolor-Doppler (ECD) and transcranial color Doppler (TCD)
To study the morphology of the venous anomalies by using intraluminal ultrasound (IVUS).
To evaluate preliminary efficacy of endovascular therapy (angioplasty) as measured by clinical (relapse rate, disability progression (EDSS)), sonographic (ECD/TCD) and MRI/MRV parameters.
To evaluate change in patients self-reported QOL following the therapeutic angioplasty
To evaluate whether changes in QOL, fatigue, MSFC or attention following therapeutic angioplasty are associated with brain changes as measured by functional MRI (fMRI).

Conditions studied

Multiple Sclerosis

Browse trials for

Multiple Sclerosis 3,264

Keywords

Multiple Sclerosis

In context

Multiple Sclerosis

3,264 studies on the registry are indexed under Multiple Sclerosis; 659 are open to participants now.

This study's enrollment of 30 is below the median of 50 across 2,201 interventional studies indexed under Multiple Sclerosis.

Browse Multiple Sclerosis studies →

Lead sponsor

University at Buffalo is the lead sponsor of 76 studies on the registry; none are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 6 (86%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 65 Years
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Age 18-65 years
- EDSS 0-6.5
- Diagnosis of relapsing MS according to the McDonald criteria (Polman et al., 2005)
- Be on treatment with currently FDA approved disease-modifying treatments
- Evidence of ≥2 sonographic parameters of suspicious abnormal extracranial cerebral venous outflow (see Table 1 background and 1.5 section)
- Demonstration of venous occlusive disease on cervical MRV
- Normal renal function: level of >60:

Constant= 1.23 for men; 1.04 for women

Exclusion criteria

Exclusion Criteria:

- Relapse, disease progression and treatment in the 30 days preceding study entry
  - Pre-existing medical conditions known to be associated with brain pathology (e.g., neurodegenerative disorder, cerebrovascular disease, positive history of alcohol abuse, etc.)
  - Severe peripheral chronic venous insufficiency
  - Abnormal renal function
  - Contrast allergy (anaphylaxis)
  - Not accepting to undergo the endovascular treatment
  - Peripheral Vascular Disease

Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Triple (Participant, Care provider, Outcomes assessor)
Enrollment: 30 participants (actual)

Study arms

Experimental
Venous Angioplasty
20 patients will have venous angio plasty
Other: Venous Angioplasty
Sham comparator
Angio with no plasty
Patients will be brought to the angio suite and given and angio but no plasty although patient will not be aware of which treatment they are having.
Other: Sham Angioplasty

Interventions

OtherVenous Angioplasty
venous angiogram to look for lesions or flaps and then plastying vessels open.
OtherSham Angioplasty
Patients will be brought to the angio suite and will not know if they are having the venous angioplasty or not.

What researchers measure

Primary outcomes

Percentage of Patients With Immediate and Short-term SAE
Percent (%) of patients with Severe Adverse Events (SAE) measured at 1 month (Short term) post-surgical safety outcome in MS patients diagnosed with CCSVI that underwent therapeutic angioplasty. The 95% confidence interval of the SAE rates for immediate and short terms will be obtained by the exact method, respectively. The immediate and short term SAE rates will be analyzed, respectively, using the Fisher's exact test.
Time frame: 1 month post-procedure

Results

Posted Aug 22, 2025

Participant flow

Participant flow — Overall Study
Milestone	Venous Angioplasty	Angio With no Plasty
Started	10	10
Completed	9	10
Not completed	1	0

Outcome measures

PrimaryPercentage of Patients With Immediate and Short-term SAE

Percent (%) of patients with Severe Adverse Events (SAE) measured at 1 month (Short term) post-surgical safety outcome in MS patients diagnosed with CCSVI that underwent therapeutic angioplasty. The 95% confidence interval of the SAE rates for immediate and short terms will be obtained by the exact method, respectively. The immediate and short term SAE rates will be analyzed, respectively, using the Fisher's exact test.

Time frame:: 1 month post-procedure
Reported as:: Count of participants · Participants

Percentage of Patients With Immediate and Short-term SAE
Participants	Venous Angioplasty	Angio With no Plasty
Percentage of Patients With Immediate and Short-term SAE	0	0

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Venous Angioplasty	—	0/9 (0%)	3/9 (33.3%)
Angio With no Plasty	—	0/10 (0%)	3/10 (30%)

Most frequent other events

Most frequent other events
Event	Venous Angioplasty	Angio With no Plasty
Cardiac eventCardiac disorders	1/9	0/10
Swelling & SorenessGeneral disorders	1/9	0/10
Transobturator slingRenal and urinary disorders	1/9	0/10
Immune thrombocytopenic purpuraImmune system disorders	0/9	1/10
Bladder infectionRenal and urinary disorders	0/9	1/10
ShinglesNervous system disorders	0/9	1/10

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Venous Angioplasty	Angio With no Plasty	Total
Mean	43.3 ± 8.2	44.8 ± 10.5	44.1 ± 9.4

Sex: Female, Male
Sex: Female, Male(Participants)	Venous Angioplasty	Angio With no Plasty	Total
Female	5	8	13
Male	4	2	6

Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)	Venous Angioplasty	Angio With no Plasty	Total
Count of participants	—	—	0

Region of Enrollment
Region of Enrollment(Participants)	Venous Angioplasty	Angio With no Plasty	Total
United States	9	10	19

Study locations

1 site

Gates Circle Hospital
Buffalo, New York 14209, United States

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Aug 22, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05380362
Lead sponsor: University at Buffalo
Collaborators: Volcano Corporation
Responsible party: Adnan H. Siddiqui (MD, PhD, Associate Professor of Neurosurgery and Radiology, University at Buffalo) — Principal investigator
First posted: May 18, 2022
Start date: Jun 2010
Primary completion: Apr 2013
Completion: Apr 2013
Results posted: Aug 22, 2025
Last update: Aug 22, 2025

Study contacts

Adnan H Siddiqui, M.D., Ph. D.

principal investigator · University at Buffalo Neurosurgery

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

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