Prospective Randomized Endovascular Therapy in Multiple Sclerosis

NCT ID: NCT05380362

Last Updated: 2025-08-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-30
• Study Completion Date: 2013-04-30

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).

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Venous Angioplasty

20 patients will have venous angio plasty

Group Type: EXPERIMENTAL

Venous Angioplasty

Intervention Type: OTHER

venous angiogram to look for lesions or flaps and then plastying vessels open.

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.

Group Type: SHAM_COMPARATOR

Sham Angioplasty

Intervention Type: OTHER

Patients will be brought to the angio suite and will not know if they are having the venous angioplasty or not.

Interventions

Venous Angioplasty

venous angiogram to look for lesions or flaps and then plastying vessels open.

Intervention Type: OTHER

Sham Angioplasty

Patients will be brought to the angio suite and will not know if they are having the venous angioplasty or not.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Volcano Corporation

INDUSTRY

Sponsor Role: collaborator

University at Buffalo

OTHER

Sponsor Role: lead

Responsible Party

Adnan H. Siddiqui

MD, PhD, Associate Professor of Neurosurgery and Radiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

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

Role: PRINCIPAL_INVESTIGATOR

University at Buffalo Neurosurgery

Locations

Gates Circle Hospital

Buffalo, New York, United States

Countries

United States

Other Identifiers

NSG1730210B

Identifier Type: OTHER

Identifier Source: secondary_id

PREM 01

Identifier Type: -

Identifier Source: org_study_id