Prospective Randomized Endovascular Therapy in Multiple Sclerosis

Multiple Sclerosis Clinical Trial

— PREMiSe  

Official title:

Prospective Randomized Endovascular Therapy in Multiple Sclerosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05380362
• Other study ID #: PREM 01
• Secondary ID: NSG1730210B
• Status: Completed
• Phase: Phase 1
• Start date: June 2010
• Est. completion date: April 2013

Study information

• Verified date: May 2022
• Source: University at Buffalo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

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

Locations

Country	Name	City	State
United States	Gates Circle Hospital	Buffalo	New York

Sponsors (2)

Lead Sponsor	Collaborator
University at Buffalo	Volcano Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SAE	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	24 hours