Prospective Randomized Endovascular Therapy in Multiple Sclerosis

Phase 2

Completed

• Conditions: Multiple Sclerosis
• Interventions: Other: Venous Angioplasty; Other: Sham Angioplasty

• Registration Number: NCT05380362
• Lead Sponsor: University at Buffalo

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Study First Submitted: 2013-04-17
• Study First Submitted QC: 2022-05-17
• Study First Posted: 2022-05-18
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-01
• Last Update Posted: 2024-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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: creatinine clearance level of >60:

Constant= 1.23 for men; 1.04 for women

Exclusion Criteria

• • Relapse, disease progression and steroid 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Venous Angioplasty	Venous Angioplasty	20 patients will have venous angio plasty
Angio with no plasty	Sham Angioplasty	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.

Primary Outcome Measures

Name	Time	Method
SAE	24 hours	Severe Adverse Events measured at 24 hours Immediate and 1 month Short term post-surgical safety outcome in MS patients diagnosed with CCSVI that underwent therapeutic angioplasty

Trial Locations

Locations (1)

Gates Circle Hospital; 🇺🇸 Buffalo, New York, United States