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NCT05380362 · ClinicalTrials.gov registry record · NA
Prospective Randomized Endovascular Therapy in Multiple Sclerosis
A NA study, sponsored by University at Buffalo.
- Completed
- Registry status
- NA
- Development phase
- 30
- Enrollment target
NCT05380362: Completed NA study, sponsored by University at Buffalo.
NCT05380362 is a NA study that has completed, run by University at Buffalo. The registered enrollment target is 30 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05380362, a NA study, has completed, sponsored by University at Buffalo.
- COMPLETED
- Registry status
- NA
- Development phase
- 30 participants
- Enrollment target
Study Summary
1. 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) 2. To study the morphology of the venous anomalies by using intraluminal ultrasound (IVUS). 3. To evaluate preliminary efficacy of endovascular therapy (angioplasty) as measured by clinical (relapse rate, disability progression (EDSS)), sonographic (ECD/TCD) and MRI/MRV parameters. 4. To evaluate change in patients self-reported QOL following the therapeutic angioplasty 5. To evaluate whether changes in QOL, fatigue, MSFC or attention following therapeutic angioplasty are associated with brain changes as measured by functional MRI (fMRI).
Primary Outcome
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.
Interventions
- OTHER Venous Angioplasty
- OTHER Sham Angioplasty
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2010-06 |
| Est. Completion | 2013-04 |
| Phase | NA |
What the finished NCT05380362 record still lists
NCT05380362 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which Venous Angioplasty is the first listed.
NCT05380362 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05380362 about?
NCT05380362 is a clinical study titled "Prospective Randomized Endovascular Therapy in Multiple Sclerosis". 1. 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) 2. To study the morphology of the venous anomalies by using intraluminal ultraso...
What is the current status of trial NCT05380362?
This trial is currently completed. It is a NA study. The enrollment target is 30 participants. The study started on 2010-06. Estimated completion is 2013-04.
What interventions are being tested in trial NCT05380362?
The interventions under investigation include: Venous Angioplasty (OTHER), Sham Angioplasty (OTHER).
Who is sponsoring clinical trial NCT05380362?
This trial is sponsored by University at Buffalo, which has 67 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05380362's enrollment target sits among peer trials
30 1593rd of 2000 higher than 299 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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