Prospective Randomized Endovascular Therapy in Multiple Sclerosis (PREMiSe)

University at Buffalo

Status: Completed

Conditions: Multiple Sclerosis

Treatments: Other: Venous Angioplasty; Other: Sham Angioplasty

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05380362

NSG1730210B

PREM 01

Details and patient eligibility

About

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).

Enrollment: 30 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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30 participants in 2 patient groups

Venous Angioplasty

Experimental group

Description:

20 patients will have venous angio plasty

Treatment:

Other: Venous Angioplasty

Angio with no plasty

Sham Comparator group

Description:

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.

Treatment:

Other: Sham Angioplasty