Prospective Randomized Endovascular Therapy in Multiple Sclerosis

NCT05380362 | Completed Results DMC

• 2 other identifiers: PREM 01NSG1730210B
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 2.To study the morphology of the venous anomalies by using intraluminal ultrasound (IVUS).
3. 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. 4.To evaluate change in patients self-reported QOL following the therapeutic angioplasty
5. 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

Keywords

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• Percentage of Patients With Immediate and Short-term SAE

  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.

  1 month post-procedure

Study Arms (2)

Venous Angioplasty

EXPERIMENTAL

20 patients will have venous angio plasty

Other: Venous Angioplasty

Angio with no plasty

SHAM COMPARATOR

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.

Other: Sham Angioplasty

Interventions

Venous Angioplasty OTHER

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

Venous Angioplasty

Sham Angioplasty OTHER

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

Angio with no plasty

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University at Buffalo: lead
• Volcano Corporation: collaborator

Study Sites (1)

Gates Circle Hospital

Buffalo, New York, 14209, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Dr. Ellen Carl
• Organization: UBNS

ecarl@ubns.com

716-218-1000

Study Officials

• Adnan H Siddiqui, M.D., Ph. D.

  University at Buffalo Neurosurgery

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Associate Professor of Neurosurgery and Radiology

Study Record Dates

• First Submitted: April 17, 2013
• First Posted: May 18, 2022
• Study Start: June 1, 2010
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: August 22, 2025
• Results First Posted: August 22, 2025

Record last verified: 2025-08

Locations

US (1)